Isotretinoin Oral Capsule
- Brand(s)
- Absorica, Amnesteem, Claravis, Myorisan, Zenatane
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Ranbaxy Laboratories Inc (2014-08-27)
- Oldest Current Product
- 2002-11-11
- License(s)
- NDA, ANDA
- RxNORM
- ORAL CAPSULE\ISOTRETINOIN
- FDAOB
- ORAL\CAPSULE\ISOTRETINOIN
- SPL Active
- ORAL\CAPSULE, GELATIN COATED\ISOTRETINOIN
ORAL\CAPSULE, LIQUID FILLED\ISOTRETINOIN
ORAL\CAPSULE\ISOTRETINOIN - SPL Moiety
- ORAL\CAPSULE, GELATIN COATED\ISOTRETINOIN
ORAL\CAPSULE, LIQUID FILLED\ISOTRETINOIN
ORAL\CAPSULE\ISOTRETINOIN
product(s) by strength(s)
isotretinoin 10 mg oral capsule
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 106310115 | Absorica | NDA | Ranbaxy Laboratories Inc | 2012-06-08 | ISOTRETINOIN | ORAL | CAPSULE | NDA021951 | 8d54aab5-3349-4a41-8533-0a566fd7bbaa |
generic product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 003786611 | Amnesteem | ANDA | Mylan Pharmaceuticals Inc. | 2002-11-11 | ISOTRETINOIN | ORAL | CAPSULE | ANDA075945 | b2cb63c9-f825-4991-9a2c-6260f1bbcc2c |
| 2 | 005551054 | Claravis | ANDA | Barr Laboratories Inc. | 2003-05-09 | ISOTRETINOIN | ORAL | CAPSULE | ANDA076356 | a31fd109-d0fd-4ab9-ba98-a3d64333c18d |
| 3 | 551110135 | Zenatane | ANDA | Dr. Reddy'S Laboratories Ltd | 2013-03-26 | ISOTRETINOIN | ORAL | CAPSULE, GELATIN COATED | ANDA202099 | 27b3cf26-f22e-5b70-1c24-009933b7c6ee |
| 4 | 617480301 | Myorisan | ANDA | Versapharm Incorporated | 2012-05-01 | ISOTRETINOIN | ORAL | CAPSULE, LIQUID FILLED | ANDA076485 | 51ff6346-9256-4c01-9f52-417d13f2df05 |
relabeler product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 548685039 | Amnesteem | ANDA | Physicians Total Care, Inc. | 2010-11-02 | ISOTRETINOIN | ORAL | CAPSULE | 003786611 | ANDA075945 | 0018861f-1b9b-431b-84ee-9d34aab615c3 |
isotretinoin 20 mg oral capsule
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 106310116 | Absorica | NDA | Ranbaxy Laboratories Inc | 2012-06-08 | ISOTRETINOIN | ORAL | CAPSULE | NDA021951 | 8d54aab5-3349-4a41-8533-0a566fd7bbaa |
generic product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 003786612 | Amnesteem | ANDA | Mylan Pharmaceuticals Inc. | 2002-11-11 | ISOTRETINOIN | ORAL | CAPSULE | ANDA075945 | b2cb63c9-f825-4991-9a2c-6260f1bbcc2c |
| 2 | 005551055 | Claravis | ANDA | Barr Laboratories Inc. | 2003-05-09 | ISOTRETINOIN | ORAL | CAPSULE | ANDA076135 | a31fd109-d0fd-4ab9-ba98-a3d64333c18d |
| 3 | 551110136 | Zenatane | ANDA | Dr. Reddy'S Laboratories Ltd | 2013-03-26 | ISOTRETINOIN | ORAL | CAPSULE, GELATIN COATED | ANDA202099 | 27b3cf26-f22e-5b70-1c24-009933b7c6ee |
| 4 | 617480302 | Myorisan | ANDA | Versapharm Incorporated | 2012-05-01 | ISOTRETINOIN | ORAL | CAPSULE, LIQUID FILLED | ANDA076485 | 51ff6346-9256-4c01-9f52-417d13f2df05 |
relabeler product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 548685041 | Amnesteem | ANDA | Physicians Total Care, Inc. | 2009-09-14 | ISOTRETINOIN | ORAL | CAPSULE | 003786612 | ANDA075945 | 0018861f-1b9b-431b-84ee-9d34aab615c3 |
| 2 | 548686307 | Claravis | ANDA | Physicians Total Care, Inc. | 2011-09-14 | ISOTRETINOIN | ORAL | CAPSULE | 005551055 | ANDA076135 | ee862463-77c0-4694-bba8-97274f13963f |
| 3 | 548686378 | Myorisan | ANDA | Physicians Total Care, Inc. | 2012-10-29 | ISOTRETINOIN | ORAL | CAPSULE, LIQUID FILLED | 617480302 | ANDA076485 | d8429009-c317-4618-a971-b0c6f1280d1a |
| 4 | 548686425 | Zenatane | ANDA | Physicians Total Care, Inc. | 2014-05-16 | ISOTRETINOIN | ORAL | CAPSULE, GELATIN COATED | 551110136 | ANDA202099 | 517810a4-76bb-4739-893f-1f2ba94a5d0c |
isotretinoin 25 mg oral capsule
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 106310133 | Absorica | NDA | Ranbaxy Laboratories Inc | 2012-06-08 | ISOTRETINOIN | ORAL | CAPSULE | NDA021951 | 8d54aab5-3349-4a41-8533-0a566fd7bbaa |
isotretinoin 30 mg oral capsule
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 106310117 | Absorica | NDA | Ranbaxy Laboratories Inc | 2012-06-08 | ISOTRETINOIN | ORAL | CAPSULE | NDA021951 | 8d54aab5-3349-4a41-8533-0a566fd7bbaa |
generic product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 005551056 | Claravis | ANDA | Barr Laboratories Inc. | 2006-05-18 | ISOTRETINOIN | ORAL | CAPSULE | ANDA076135 | a31fd109-d0fd-4ab9-ba98-a3d64333c18d |
| 2 | 551110113 | Zenatane | ANDA | Dr. Reddy'S Laboratories Ltd | 2015-03-09 | ISOTRETINOIN | ORAL | CAPSULE, GELATIN COATED | ANDA202099 | 27b3cf26-f22e-5b70-1c24-009933b7c6ee |
| 3 | 617480303 | Myorisan | ANDA | Versapharm Incorporated | 2015-08-26 | ISOTRETINOIN | ORAL | CAPSULE, LIQUID FILLED | ANDA076485 | 51ff6346-9256-4c01-9f52-417d13f2df05 |
relabeler product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 548686185 | Claravis | ANDA | Physicians Total Care, Inc. | 2013-10-04 | ISOTRETINOIN | ORAL | CAPSULE | 005551056 | ANDA076135 | ee862463-77c0-4694-bba8-97274f13963f |
isotretinoin 35 mg oral capsule
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 106310134 | Absorica | NDA | Ranbaxy Laboratories Inc | 2012-06-08 | ISOTRETINOIN | ORAL | CAPSULE | NDA021951 | 8d54aab5-3349-4a41-8533-0a566fd7bbaa |
isotretinoin 40 mg oral capsule
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 106310118 | Absorica | NDA | Ranbaxy Laboratories Inc | 2012-06-08 | ISOTRETINOIN | ORAL | CAPSULE | NDA021951 | 8d54aab5-3349-4a41-8533-0a566fd7bbaa |
generic product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 003786614 | Amnesteem | ANDA | Mylan Pharmaceuticals Inc. | 2002-11-11 | ISOTRETINOIN | ORAL | CAPSULE | ANDA075945 | b2cb63c9-f825-4991-9a2c-6260f1bbcc2c |
| 2 | 005551057 | Claravis | ANDA | Barr Laboratories Inc. | 2003-05-09 | ISOTRETINOIN | ORAL | CAPSULE | ANDA076135 | a31fd109-d0fd-4ab9-ba98-a3d64333c18d |
| 3 | 551110137 | Zenatane | ANDA | Dr. Reddy'S Laboratories Ltd | 2013-03-26 | ISOTRETINOIN | ORAL | CAPSULE, GELATIN COATED | ANDA202099 | 27b3cf26-f22e-5b70-1c24-009933b7c6ee |
| 4 | 617480304 | Myorisan | ANDA | Versapharm Incorporated | 2012-05-01 | ISOTRETINOIN | ORAL | CAPSULE, LIQUID FILLED | ANDA076485 | 51ff6346-9256-4c01-9f52-417d13f2df05 |
relabeler product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 548685043 | Amnesteem | ANDA | Physicians Total Care, Inc. | 2009-07-14 | ISOTRETINOIN | ORAL | CAPSULE | 003786614 | ANDA075945 | 0018861f-1b9b-431b-84ee-9d34aab615c3 |
| 2 | 548686308 | Claravis | ANDA | Physicians Total Care, Inc. | 2011-09-20 | ISOTRETINOIN | ORAL | CAPSULE | 005551057 | ANDA076135 | ee862463-77c0-4694-bba8-97274f13963f |
| 3 | 548686366 | Myorisan | ANDA | Physicians Total Care, Inc. | 2012-08-23 | ISOTRETINOIN | ORAL | CAPSULE, LIQUID FILLED | 617480304 | ANDA076485 | d8429009-c317-4618-a971-b0c6f1280d1a |
| 4 | 548686426 | Zenatane | ANDA | Physicians Total Care, Inc. | 2014-05-16 | ISOTRETINOIN | ORAL | CAPSULE, GELATIN COATED | 551110137 | ANDA202099 | 517810a4-76bb-4739-893f-1f2ba94a5d0c |
application(s)
| # | id | title | deprecated | applicant | approved | patent | exclusivity | approved drug |
|---|---|---|---|---|---|---|---|---|
| 1 | ANDA075945 | AMNESTEEM | MYLAN PHARMACEUTICALS INC | 2002-11-08 | ANDA075945_001, ANDA075945_002, ANDA075945_003 | |||
| 2 | ANDA076041 | SOTRET | SUN PHARMACEUTICAL INDUSTRIES LTD | 2002-12-24 | ANDA076041_001, ANDA076041_002, ANDA076041_003 | |||
| 3 | ANDA076135 | CLARAVIS | TEVA PHARMACEUTICALS USA | 2003-04-11 | ANDA076135_001, ANDA076135_002, ANDA076135_003 | |||
| 4 | ANDA076356 | CLARAVIS | TEVA PHARMACEUTICALS USA | 2003-04-11 | ANDA076356_001 | |||
| 5 | ANDA076485 | MYORISAN | DOUGLAS PHARMACEUTICALS AMERICA LTD | 2012-01-19 | ANDA076485_001, ANDA076485_002, ANDA076485_003, ANDA076485_004 | |||
| 6 | ANDA076503 | SOTRET | SUN PHARMACEUTICAL INDUSTRIES LTD | 2003-06-20 | ANDA076503_001 | |||
| 7 | ANDA202099 | ZENATANE | DR REDDYS LABORATORIES LTD | 2013-03-25 | ANDA202099_001, ANDA202099_002, ANDA202099_003, ANDA202099_004 | |||
| 8 | NDA018662 | ACCUTANE | True | HOFFMANN LA ROCHE INC | 1982-05-07 | NDA018662_002, NDA018662_003, NDA018662_004 | ||
| 9 | NDA021951 | ABSORICA | RANBAXY INC | 2012-05-25 | p8367102, TREATMENT OF A SKIN DISORDER p9089534, SUBSTANCE p9078925, SUBSTANCE p7435427, SUBSTANCE p8952064, SUBSTANCE | NEW PRODUCT [2015-05-25] | NDA021951_001, NDA021951_002, NDA021951_003, NDA021951_004, NDA021951_005, NDA021951_006 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|---|
| 1 | ANDA075945_001 | RX | ISOTRETINOIN (10MG) | ORAL | CAPSULE | False | AB | 2002-11-08 | AMNESTEEM |
| 2 | ANDA075945_002 | RX | ISOTRETINOIN (20MG) | ORAL | CAPSULE | False | AB | 2002-11-08 | AMNESTEEM |
| 3 | ANDA075945_003 | RX | ISOTRETINOIN (40MG) | ORAL | CAPSULE | False | AB | 2002-11-08 | AMNESTEEM |
| 4 | ANDA076041_001 | RX | ISOTRETINOIN (10MG) | ORAL | CAPSULE | False | AB | 2002-12-24 | SOTRET |
| 5 | ANDA076041_002 | RX | ISOTRETINOIN (20MG) | ORAL | CAPSULE | False | AB | 2002-12-24 | SOTRET |
| 6 | ANDA076041_003 | RX | ISOTRETINOIN (40MG) | ORAL | CAPSULE | False | AB | 2002-12-24 | SOTRET |
| 7 | ANDA076135_001 | RX | ISOTRETINOIN (40MG) | ORAL | CAPSULE | True | AB | 2003-04-11 | CLARAVIS |
| 8 | ANDA076135_002 | RX | ISOTRETINOIN (20MG) | ORAL | CAPSULE | False | AB | 2003-04-11 | CLARAVIS |
| 9 | ANDA076135_003 | RX | ISOTRETINOIN (30MG) | ORAL | CAPSULE | False | AB | 2006-05-11 | CLARAVIS |
| 10 | ANDA076356_001 | RX | ISOTRETINOIN (10MG) | ORAL | CAPSULE | False | AB | 2003-04-11 | CLARAVIS |
| 11 | ANDA076485_001 | RX | ISOTRETINOIN (10MG) | ORAL | CAPSULE | False | AB | 2012-01-19 | MYORISAN |
| 12 | ANDA076485_002 | RX | ISOTRETINOIN (20MG) | ORAL | CAPSULE | False | AB | 2012-01-19 | MYORISAN |
| 13 | ANDA076485_003 | RX | ISOTRETINOIN (40MG) | ORAL | CAPSULE | False | AB | 2012-01-19 | MYORISAN |
| 14 | ANDA076485_004 | RX | ISOTRETINOIN (30MG) | ORAL | CAPSULE | False | AB | 2015-08-25 | MYORISAN |
| 15 | ANDA076503_001 | RX | ISOTRETINOIN (30MG) | ORAL | CAPSULE | False | AB | 2003-06-20 | SOTRET |
| 16 | ANDA202099_001 | RX | ISOTRETINOIN (10MG) | ORAL | CAPSULE | False | AB | 2013-03-25 | ZENATANE |
| 17 | ANDA202099_002 | RX | ISOTRETINOIN (20MG) | ORAL | CAPSULE | False | AB | 2013-03-25 | ZENATANE |
| 18 | ANDA202099_003 | RX | ISOTRETINOIN (40MG) | ORAL | CAPSULE | False | AB | 2013-03-25 | ZENATANE |
| 19 | ANDA202099_004 | RX | ISOTRETINOIN (30MG) | ORAL | CAPSULE | False | AB | 2015-02-23 | ZENATANE |
| 20 | NDA018662_002 | discontinued | ISOTRETINOIN (10MG) | ORAL | CAPSULE | False | 1982-05-07 | ACCUTANE | |
| 21 | NDA018662_003 | discontinued | ISOTRETINOIN (40MG) | ORAL | CAPSULE | False | 1982-05-07 | ACCUTANE | |
| 22 | NDA018662_004 | discontinued | ISOTRETINOIN (20MG) | ORAL | CAPSULE | False | 1983-03-28 | ACCUTANE | |
| 23 | NDA021951_001 | RX | ISOTRETINOIN (10MG) | ORAL | CAPSULE | False | BX | 2012-05-25 | ABSORICA |
| 24 | NDA021951_002 | RX | ISOTRETINOIN (20MG) | ORAL | CAPSULE | False | BX | 2012-05-25 | ABSORICA |
| 25 | NDA021951_003 | RX | ISOTRETINOIN (30MG) | ORAL | CAPSULE | False | BX | 2012-05-25 | ABSORICA |
| 26 | NDA021951_004 | RX | ISOTRETINOIN (40MG) | ORAL | CAPSULE | True | BX | 2012-05-25 | ABSORICA |
| 27 | NDA021951_005 | RX | ISOTRETINOIN (25MG) | ORAL | CAPSULE | False | 2014-08-15 | ABSORICA | |
| 28 | NDA021951_006 | RX | ISOTRETINOIN (35MG) | ORAL | CAPSULE | False | 2014-08-15 | ABSORICA |
patent(s)
| # | id | expiration date | application(s) |
|---|---|---|---|
| 1 | p7435427 (view patent) | 2021-09-21 | NDA021951 |
| 2 | p8367102 (view patent) | 2021-09-21 | NDA021951 |
| 3 | p8952064 (view patent) | 2021-09-21 | NDA021951 |
| 4 | p9078925 (view patent) | 2021-09-21 | NDA021951 |
| 5 | p9089534 (view patent) | 2021-09-21 | NDA021951 |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 0018861f-1b9b-431b-84ee-9d34aab615c3 (view SPL) | prescription | Human Prescription | Physicians Total Care, Inc. | relabel | 2012-06-25 | 5 | 548685039, 548685041, 548685043 | |
| 2 | 27b3cf26-f22e-5b70-1c24-009933b7c6ee (view SPL) | Isotretinoin Capsules USP | prescription | Human Prescription | Dr. Reddy'S Laboratories Ltd | analysis, manufacture | 2015-06-26 | 11 | 551110113, 551110135, 551110136, 551110137 |
| 3 | 517810a4-76bb-4739-893f-1f2ba94a5d0c (view SPL) | Isotretinoin Capsules USP | prescription | Human Prescription | Physicians Total Care, Inc. | relabel | 2014-08-22 | 1 | 548686425, 548686426 |
| 4 | 51ff6346-9256-4c01-9f52-417d13f2df05 (view SPL) | Myorisan (isotretinoin capsules, USP) 10 mg, 20 mg, 30 mg, 40 mg | prescription | Human Prescription | Versapharm Incorporated | MANUFACTURE | 2015-09-30 | 9 | 617480301, 617480302, 617480303, 617480304 |
| 5 | 8d54aab5-3349-4a41-8533-0a566fd7bbaa (view SPL) | These highlights do not include all the information needed to use ABSORICA safely and effectively. See full prescribing information for ABSORICA.ABSORICA (isotretinoin) capsules, for oral useInitial U.S. Approval: 1982 | prescription | Human Prescription | Ranbaxy Laboratories Inc | ANALYSIS, API MANUFACTURE, MANUFACTURE, PACK | 2014-08-27 | 4 | 106310115, 106310116, 106310117, 106310118, 106310133, 106310134 |
| 6 | a31fd109-d0fd-4ab9-ba98-a3d64333c18d (view SPL) | CLARAVIS(isotretinoin capsules USP) | prescription | Human Prescription | Barr Laboratories Inc. | 2015-09-16 | 8 | 005551054, 005551055, 005551056, 005551057 | |
| 7 | b2cb63c9-f825-4991-9a2c-6260f1bbcc2c (view SPL) | prescription | Human Prescription | Mylan Pharmaceuticals Inc. | 2015-03-06 | 7 | 003786611, 003786612, 003786614 | ||
| 8 | d8429009-c317-4618-a971-b0c6f1280d1a (view SPL) | MyorisanTM (isotretinoin capsules, USP) 10 mg, 20 mg, 40 mg | prescription | Human Prescription | Physicians Total Care, Inc. | relabel | 2013-01-02 | 2 | 548686366, 548686378 |
| 9 | ee862463-77c0-4694-bba8-97274f13963f (view SPL) | CLARAVIS(isotretinoin capsules USP) | prescription | Human Prescription | Physicians Total Care, Inc. | relabel | 2014-01-20 | 4 | 548686185, 548686307, 548686308 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII