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)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1106310115AbsoricaNDARanbaxy Laboratories Inc2012-06-08ISOTRETINOINORALCAPSULENDA0219518d54aab5-3349-4a41-8533-0a566fd7bbaa

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003786611AmnesteemANDAMylan Pharmaceuticals Inc.2002-11-11ISOTRETINOINORALCAPSULEANDA075945b2cb63c9-f825-4991-9a2c-6260f1bbcc2c
2005551054ClaravisANDABarr Laboratories Inc.2003-05-09ISOTRETINOINORALCAPSULEANDA076356a31fd109-d0fd-4ab9-ba98-a3d64333c18d
3551110135ZenataneANDADr. Reddy'S Laboratories Ltd2013-03-26ISOTRETINOINORALCAPSULE, GELATIN COATEDANDA20209927b3cf26-f22e-5b70-1c24-009933b7c6ee
4617480301MyorisanANDAVersapharm Incorporated2012-05-01ISOTRETINOINORALCAPSULE, LIQUID FILLEDANDA07648551ff6346-9256-4c01-9f52-417d13f2df05

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685039AmnesteemANDAPhysicians Total Care, Inc.2010-11-02ISOTRETINOINORALCAPSULE003786611ANDA0759450018861f-1b9b-431b-84ee-9d34aab615c3

isotretinoin 20 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1106310116AbsoricaNDARanbaxy Laboratories Inc2012-06-08ISOTRETINOINORALCAPSULENDA0219518d54aab5-3349-4a41-8533-0a566fd7bbaa

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003786612AmnesteemANDAMylan Pharmaceuticals Inc.2002-11-11ISOTRETINOINORALCAPSULEANDA075945b2cb63c9-f825-4991-9a2c-6260f1bbcc2c
2005551055ClaravisANDABarr Laboratories Inc.2003-05-09ISOTRETINOINORALCAPSULEANDA076135a31fd109-d0fd-4ab9-ba98-a3d64333c18d
3551110136ZenataneANDADr. Reddy'S Laboratories Ltd2013-03-26ISOTRETINOINORALCAPSULE, GELATIN COATEDANDA20209927b3cf26-f22e-5b70-1c24-009933b7c6ee
4617480302MyorisanANDAVersapharm Incorporated2012-05-01ISOTRETINOINORALCAPSULE, LIQUID FILLEDANDA07648551ff6346-9256-4c01-9f52-417d13f2df05

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685041AmnesteemANDAPhysicians Total Care, Inc.2009-09-14ISOTRETINOINORALCAPSULE003786612ANDA0759450018861f-1b9b-431b-84ee-9d34aab615c3
2548686307ClaravisANDAPhysicians Total Care, Inc.2011-09-14ISOTRETINOINORALCAPSULE005551055ANDA076135ee862463-77c0-4694-bba8-97274f13963f
3548686378MyorisanANDAPhysicians Total Care, Inc.2012-10-29ISOTRETINOINORALCAPSULE, LIQUID FILLED617480302ANDA076485d8429009-c317-4618-a971-b0c6f1280d1a
4548686425ZenataneANDAPhysicians Total Care, Inc.2014-05-16ISOTRETINOINORALCAPSULE, GELATIN COATED551110136ANDA202099517810a4-76bb-4739-893f-1f2ba94a5d0c

isotretinoin 25 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1106310133AbsoricaNDARanbaxy Laboratories Inc2012-06-08ISOTRETINOINORALCAPSULENDA0219518d54aab5-3349-4a41-8533-0a566fd7bbaa

isotretinoin 30 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1106310117AbsoricaNDARanbaxy Laboratories Inc2012-06-08ISOTRETINOINORALCAPSULENDA0219518d54aab5-3349-4a41-8533-0a566fd7bbaa

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005551056ClaravisANDABarr Laboratories Inc.2006-05-18ISOTRETINOINORALCAPSULEANDA076135a31fd109-d0fd-4ab9-ba98-a3d64333c18d
2551110113ZenataneANDADr. Reddy'S Laboratories Ltd2015-03-09ISOTRETINOINORALCAPSULE, GELATIN COATEDANDA20209927b3cf26-f22e-5b70-1c24-009933b7c6ee
3617480303MyorisanANDAVersapharm Incorporated2015-08-26ISOTRETINOINORALCAPSULE, LIQUID FILLEDANDA07648551ff6346-9256-4c01-9f52-417d13f2df05

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548686185ClaravisANDAPhysicians Total Care, Inc.2013-10-04ISOTRETINOINORALCAPSULE005551056ANDA076135ee862463-77c0-4694-bba8-97274f13963f

isotretinoin 35 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1106310134AbsoricaNDARanbaxy Laboratories Inc2012-06-08ISOTRETINOINORALCAPSULENDA0219518d54aab5-3349-4a41-8533-0a566fd7bbaa

isotretinoin 40 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1106310118AbsoricaNDARanbaxy Laboratories Inc2012-06-08ISOTRETINOINORALCAPSULENDA0219518d54aab5-3349-4a41-8533-0a566fd7bbaa

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003786614AmnesteemANDAMylan Pharmaceuticals Inc.2002-11-11ISOTRETINOINORALCAPSULEANDA075945b2cb63c9-f825-4991-9a2c-6260f1bbcc2c
2005551057ClaravisANDABarr Laboratories Inc.2003-05-09ISOTRETINOINORALCAPSULEANDA076135a31fd109-d0fd-4ab9-ba98-a3d64333c18d
3551110137ZenataneANDADr. Reddy'S Laboratories Ltd2013-03-26ISOTRETINOINORALCAPSULE, GELATIN COATEDANDA20209927b3cf26-f22e-5b70-1c24-009933b7c6ee
4617480304MyorisanANDAVersapharm Incorporated2012-05-01ISOTRETINOINORALCAPSULE, LIQUID FILLEDANDA07648551ff6346-9256-4c01-9f52-417d13f2df05

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685043AmnesteemANDAPhysicians Total Care, Inc.2009-07-14ISOTRETINOINORALCAPSULE003786614ANDA0759450018861f-1b9b-431b-84ee-9d34aab615c3
2548686308ClaravisANDAPhysicians Total Care, Inc.2011-09-20ISOTRETINOINORALCAPSULE005551057ANDA076135ee862463-77c0-4694-bba8-97274f13963f
3548686366MyorisanANDAPhysicians Total Care, Inc.2012-08-23ISOTRETINOINORALCAPSULE, LIQUID FILLED617480304ANDA076485d8429009-c317-4618-a971-b0c6f1280d1a
4548686426ZenataneANDAPhysicians Total Care, Inc.2014-05-16ISOTRETINOINORALCAPSULE, GELATIN COATED551110137ANDA202099517810a4-76bb-4739-893f-1f2ba94a5d0c

application(s)

#idtitledeprecatedapplicantapprovedpatentexclusivityapproved drug
1ANDA075945AMNESTEEMMYLAN PHARMACEUTICALS INC2002-11-08ANDA075945_001, ANDA075945_002, ANDA075945_003
2ANDA076041SOTRETSUN PHARMACEUTICAL INDUSTRIES LTD2002-12-24ANDA076041_001, ANDA076041_002, ANDA076041_003
3ANDA076135CLARAVISTEVA PHARMACEUTICALS USA2003-04-11ANDA076135_001, ANDA076135_002, ANDA076135_003
4ANDA076356CLARAVISTEVA PHARMACEUTICALS USA2003-04-11ANDA076356_001
5ANDA076485MYORISANDOUGLAS PHARMACEUTICALS AMERICA LTD2012-01-19ANDA076485_001, ANDA076485_002, ANDA076485_003, ANDA076485_004
6ANDA076503SOTRETSUN PHARMACEUTICAL INDUSTRIES LTD2003-06-20ANDA076503_001
7ANDA202099ZENATANEDR REDDYS LABORATORIES LTD2013-03-25ANDA202099_001, ANDA202099_002, ANDA202099_003, ANDA202099_004
8NDA018662ACCUTANETrueHOFFMANN LA ROCHE INC1982-05-07NDA018662_002, NDA018662_003, NDA018662_004
9NDA021951ABSORICARANBAXY INC2012-05-25p8367102, 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)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA075945_001RXISOTRETINOIN (10MG)ORALCAPSULEFalseAB2002-11-08AMNESTEEM
2ANDA075945_002RXISOTRETINOIN (20MG)ORALCAPSULEFalseAB2002-11-08AMNESTEEM
3ANDA075945_003RXISOTRETINOIN (40MG)ORALCAPSULEFalseAB2002-11-08AMNESTEEM
4ANDA076041_001RXISOTRETINOIN (10MG)ORALCAPSULEFalseAB2002-12-24SOTRET
5ANDA076041_002RXISOTRETINOIN (20MG)ORALCAPSULEFalseAB2002-12-24SOTRET
6ANDA076041_003RXISOTRETINOIN (40MG)ORALCAPSULEFalseAB2002-12-24SOTRET
7ANDA076135_001RXISOTRETINOIN (40MG)ORALCAPSULETrueAB2003-04-11CLARAVIS
8ANDA076135_002RXISOTRETINOIN (20MG)ORALCAPSULEFalseAB2003-04-11CLARAVIS
9ANDA076135_003RXISOTRETINOIN (30MG)ORALCAPSULEFalseAB2006-05-11CLARAVIS
10ANDA076356_001RXISOTRETINOIN (10MG)ORALCAPSULEFalseAB2003-04-11CLARAVIS
11ANDA076485_001RXISOTRETINOIN (10MG)ORALCAPSULEFalseAB2012-01-19MYORISAN
12ANDA076485_002RXISOTRETINOIN (20MG)ORALCAPSULEFalseAB2012-01-19MYORISAN
13ANDA076485_003RXISOTRETINOIN (40MG)ORALCAPSULEFalseAB2012-01-19MYORISAN
14ANDA076485_004RXISOTRETINOIN (30MG)ORALCAPSULEFalseAB2015-08-25MYORISAN
15ANDA076503_001RXISOTRETINOIN (30MG)ORALCAPSULEFalseAB2003-06-20SOTRET
16ANDA202099_001RXISOTRETINOIN (10MG)ORALCAPSULEFalseAB2013-03-25ZENATANE
17ANDA202099_002RXISOTRETINOIN (20MG)ORALCAPSULEFalseAB2013-03-25ZENATANE
18ANDA202099_003RXISOTRETINOIN (40MG)ORALCAPSULEFalseAB2013-03-25ZENATANE
19ANDA202099_004RXISOTRETINOIN (30MG)ORALCAPSULEFalseAB2015-02-23ZENATANE
20NDA018662_002discontinuedISOTRETINOIN (10MG)ORALCAPSULEFalse1982-05-07ACCUTANE
21NDA018662_003discontinuedISOTRETINOIN (40MG)ORALCAPSULEFalse1982-05-07ACCUTANE
22NDA018662_004discontinuedISOTRETINOIN (20MG)ORALCAPSULEFalse1983-03-28ACCUTANE
23NDA021951_001RXISOTRETINOIN (10MG)ORALCAPSULEFalseBX2012-05-25ABSORICA
24NDA021951_002RXISOTRETINOIN (20MG)ORALCAPSULEFalseBX2012-05-25ABSORICA
25NDA021951_003RXISOTRETINOIN (30MG)ORALCAPSULEFalseBX2012-05-25ABSORICA
26NDA021951_004RXISOTRETINOIN (40MG)ORALCAPSULETrueBX2012-05-25ABSORICA
27NDA021951_005RXISOTRETINOIN (25MG)ORALCAPSULEFalse2014-08-15ABSORICA
28NDA021951_006RXISOTRETINOIN (35MG)ORALCAPSULEFalse2014-08-15ABSORICA

patent(s)

#idexpiration dateapplication(s)
1p7435427 (view patent)2021-09-21NDA021951
2p8367102 (view patent)2021-09-21NDA021951
3p8952064 (view patent)2021-09-21NDA021951
4p9078925 (view patent)2021-09-21NDA021951
5p9089534 (view patent)2021-09-21NDA021951

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10018861f-1b9b-431b-84ee-9d34aab615c3 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2012-06-255548685039, 548685041, 548685043
227b3cf26-f22e-5b70-1c24-009933b7c6ee (view SPL)Isotretinoin Capsules USPprescriptionHuman PrescriptionDr. Reddy'S Laboratories Ltdanalysis, manufacture2015-06-2611551110113, 551110135, 551110136, 551110137
3517810a4-76bb-4739-893f-1f2ba94a5d0c (view SPL)Isotretinoin Capsules USPprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2014-08-221548686425, 548686426
451ff6346-9256-4c01-9f52-417d13f2df05 (view SPL)Myorisan (isotretinoin capsules, USP) 10 mg, 20 mg, 30 mg, 40 mgprescriptionHuman PrescriptionVersapharm IncorporatedMANUFACTURE2015-09-309617480301, 617480302, 617480303, 617480304
58d54aab5-3349-4a41-8533-0a566fd7bbaa (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: 1982prescriptionHuman PrescriptionRanbaxy Laboratories IncANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2014-08-274106310115, 106310116, 106310117, 106310118, 106310133, 106310134
6a31fd109-d0fd-4ab9-ba98-a3d64333c18d (view SPL)CLARAVIS(isotretinoin capsules USP)prescriptionHuman PrescriptionBarr Laboratories Inc.2015-09-168005551054, 005551055, 005551056, 005551057
7b2cb63c9-f825-4991-9a2c-6260f1bbcc2c (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-03-067003786611, 003786612, 003786614
8d8429009-c317-4618-a971-b0c6f1280d1a (view SPL)MyorisanTM (isotretinoin capsules, USP) 10 mg, 20 mg, 40 mgprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2013-01-022548686366, 548686378
9ee862463-77c0-4694-bba8-97274f13963f (view SPL)CLARAVIS(isotretinoin capsules USP)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2014-01-204548686185, 548686307, 548686308

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII