abacavir Oral Tablet
- Brand(s)
- Ziagen
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Viiv Healthcare Company (2015-09-30)
- Oldest Current Product
- 1998-12-29
- License(s)
- NDA, ANDA
- RxNORM
- ORAL TABLET\ABACAVIR
- FDAOB
- ORAL\TABLET\ABACAVIR SULFATE
- SPL Active
- ORAL\TABLET, FILM COATED\ABACAVIR SULFATE
ORAL\TABLET\ABACAVIR SULFATE - SPL Moiety
- ORAL\TABLET, FILM COATED\ABACAVIR
ORAL\TABLET\ABACAVIR
product(s) by strength(s)
abacavir 300 mg oral tablet
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 497020221 | Ziagen | NDA | Viiv Healthcare Company | 1998-12-29 | ABACAVIR SULFATE | ORAL | TABLET, FILM COATED | NDA020977 | ca73b519-015a-436d-aa3c-af53492825a1 |
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 003784105 | ANDA | Mylan Pharmaceuticals Inc. | 2012-06-19 | ABACAVIR SULFATE | ORAL | TABLET, FILM COATED | ANDA091294 | 5676d391-f9a4-44be-9604-954b3d8d0e2b |
| 2 | 317220557 | ANDA | Camber Pharmaceuticals, Inc. | 2013-09-18 | ABACAVIR SULFATE | ORAL | TABLET | ANDA091560 | 44fb1e25-ad03-4a7f-9f35-2e29f5025661 |
| 3 | 510790204 | ANDA | Mylan Institutional Inc. | 2012-08-01 | ABACAVIR SULFATE | ORAL | TABLET, FILM COATED | ANDA091294 | 80c1702a-973c-436a-90f8-69b29674dca0 |
| 4 | 605053583 | ANDA | Apotex Corp | 2012-12-17 | ABACAVIR SULFATE | ORAL | TABLET, FILM COATED | ANDA201570 | 73ce0bc5-43e2-c57f-0a6a-bdaf9fbaa3c2 |
| 5 | 658620073 | ANDA | Aurobindo Pharma Limited | 2012-12-17 | ABACAVIR SULFATE | ORAL | TABLET, FILM COATED | ANDA077844 | 5409c8ed-17c3-454f-bb88-d597ba8f84ec |
relabeler product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 493490905 | Ziagen | NDA | Remedyrepack Inc. | 2013-04-08 | ABACAVIR SULFATE | ORAL | TABLET, FILM COATED | 497020221 | NDA020977 | ced433cf-2acf-47ae-9b74-69992c3bc8e0 |
| 2 | 493490999 | ANDA | Remedyrepack Inc. | 2013-02-27 | ABACAVIR SULFATE | ORAL | TABLET, FILM COATED | 003784105 | ANDA091294 | d4c622c8-73ba-49b4-9ac5-81bf87702775 | |
| 3 | 521250956 | ANDA | Remedyrepack Inc. | 2014-05-29 | ABACAVIR SULFATE | ORAL | TABLET | 317220557 | ANDA091560 | ad60ace3-d64c-4ed7-ab0d-1d3c166357f3 | |
| 4 | 538080627 | ANDA | State Of Florida Doh Central Pharmacy | 2013-01-01 | ABACAVIR SULFATE | ORAL | TABLET, FILM COATED | 003784105 | ANDA091294 | e3961e38-20d5-4014-a9d5-1ab13611abb9 | |
| 5 | 538080811 | Ziagen | NDA | State Of Florida Doh Central Pharmacy | 2009-07-01 | ABACAVIR SULFATE | ORAL | TABLET, FILM COATED | 001730661 | NDA020977 | ff62bcaa-a200-4ebf-a9ca-1ab2c254751c |
| 6 | 680840021 | ANDA | American Health Packaging | 2013-02-07 | ABACAVIR SULFATE | ORAL | TABLET, FILM COATED | 658620073 | ANDA077844 | 01e46f58-8bda-4ff3-ab21-57d5b540d440 |
application(s)
| # | id | title | applicant | approved | patent | exclusivity | approved drug |
|---|---|---|---|---|---|---|---|
| 1 | ANDA077844 | ABACAVIR SULFATE | AUROBINDO PHARMA LTD | 2012-12-17 | ANDA077844_001 | ||
| 2 | ANDA091294 | ABACAVIR SULFATE | MYLAN PHARMACEUTICALS INC | 2012-06-18 | ANDA091294_001 | ||
| 3 | ANDA091560 | ABACAVIR SULFATE | HETERO LABS LTD UNIT III | 2013-09-13 | ANDA091560_001 | ||
| 4 | ANDA201570 | ABACAVIR SULFATE | APOTEX INC | 2012-12-17 | ANDA201570_001 | ||
| 5 | NDA020977 | ZIAGEN | VIIV HEALTHCARE CO | 1998-12-17 | p6294540, METHOD OF TREATMENT OF A PATIENT INFECTED WITH HIV, SUBSTANCE | ONCE DAILY DOSING IN PEDIATRIC PATIENTS 3 MONTHS OF AGE AND OLDER IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS FOR THE TREATMENT OF HIV-1 INFECTION [2018-03-23] | NDA020977_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|---|
| 1 | ANDA077844_001 | RX | ABACAVIR SULFATE (EQ 300MG BASE) | ORAL | TABLET | False | AB | 2012-12-17 | ABACAVIR SULFATE |
| 2 | ANDA091294_001 | RX | ABACAVIR SULFATE (EQ 300MG BASE) | ORAL | TABLET | False | AB | 2012-06-18 | ABACAVIR SULFATE |
| 3 | ANDA091560_001 | RX | ABACAVIR SULFATE (EQ 300MG BASE) | ORAL | TABLET | False | AB | 2013-09-13 | ABACAVIR SULFATE |
| 4 | ANDA201570_001 | RX | ABACAVIR SULFATE (EQ 300MG BASE) | ORAL | TABLET | False | AB | 2012-12-17 | ABACAVIR SULFATE |
| 5 | NDA020977_001 | RX | ABACAVIR SULFATE (EQ 300MG BASE) | ORAL | TABLET | True | AB | 1998-12-17 | ZIAGEN |
patent(s)
| # | id | expiration date | application(s) | in other drug docs |
|---|---|---|---|---|
| 1 | p6294540 (view patent) | 2018-05-14 | NDA020977, NDA020978, NDA021205, NDA021652, NDA205551 | abacavir / Lamivudine Oral Tablet abacavir / dolutegravir / Lamivudine Oral Tablet abacavir / Lamivudine / Zidovudine Oral Tablet abacavir Oral Solution |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) | in other drug docs |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 01e46f58-8bda-4ff3-ab21-57d5b540d440 (view SPL) | These highlights do not include all the information needed to use abacavir sulfate safely and effectively. See full prescribing information for abacavir tablets USP.ABACAVIR Tablets USP, for oral useInitial U.S. Approval: 1998 | prescription | Human Prescription | American Health Packaging | REPACK | 2015-10-16 | 2 | 680840021 | |
| 2 | 44fb1e25-ad03-4a7f-9f35-2e29f5025661 (view SPL) | These highlights do not include all the information needed to use abacavir sulfate safely and effectively. See full prescribing information for abacavir sulfate.ABACAVIR Tablets USP, for oral useInitial U.S. Approval: 1998 | prescription | Human Prescription | Camber Pharmaceuticals, Inc. | 2014-07-16 | 2 | 317220557 | ||
| 3 | 5409c8ed-17c3-454f-bb88-d597ba8f84ec (view SPL) | These highlights do not include all the information needed to use ABACAVIR TABLETSsafely and effectively. See full prescribing information for ABACAVIR TABLETS.ABACAVIRtablets, for oral useInitial U.S. Approval: 1998 | prescription | Human Prescription | Aurobindo Pharma Limited | ANALYSIS, API MANUFACTURE, MANUFACTURE | 2015-10-01 | 5 | 658620073 | |
| 4 | 5676d391-f9a4-44be-9604-954b3d8d0e2b (view SPL) | These highlights do not include all the information needed to use ABACAVIR TABLETS safely and effectively. See full prescribing information for ABACAVIR TABLETS. ABACAVIR tablets USP, for oral use Initial U.S. Approval: 1998 | prescription | Human Prescription | Mylan Pharmaceuticals Inc. | 2015-09-16 | 8 | 003784105 | ||
| 5 | 73ce0bc5-43e2-c57f-0a6a-bdaf9fbaa3c2 (view SPL) | These highlights do not include all the information needed to use ABACAVIR TABLETS, USP safely and effectively. See full prescribing information for ABACAVIR TABLETS, USP. ABACAVIR tablets, for oral use Initial U.S. Approval: 1998 | prescription | Human Prescription | Apotex Corp | analysis, manufacture | 2015-09-01 | 6 | 605053583 | |
| 6 | 80c1702a-973c-436a-90f8-69b29674dca0 (view SPL) | These highlights do not include all the information needed to use abacavir tablets safely and effectively. See full prescribing information for abacavir tablets. Abacavir Tablets, USP for Oral UseInitial U.S. Approval: 1998 | prescription | Human Prescription | Mylan Institutional Inc. | 2013-10-04 | 3 | 510790204 | ||
| 7 | ad60ace3-d64c-4ed7-ab0d-1d3c166357f3 (view SPL) | These highlights do not include all the information needed to use abacavir sulfate safely and effectively. See full prescribing information for abacavir sulfate.Abacavir Tablets USP Initial U.S. Approval: 1998 | prescription | Human Prescription | Remedyrepack Inc. | 2014-05-29 | 2 | 521250956 | ||
| 8 | ca73b519-015a-436d-aa3c-af53492825a1 (view SPL) | These highlights do not include all the information needed to use ZIAGEN safely and effectively. See full prescribing information for ZIAGEN. ZIAGEN (abacavir) tablets, for oral useZIAGEN (abacavir) oral solutionInitial U.S. Approval: 1998 | prescription | Human Prescription | Viiv Healthcare Company | 2015-09-30 | 17 | 497020221, 497020222 | abacavir Oral Solution | |
| 9 | ced433cf-2acf-47ae-9b74-69992c3bc8e0 (view SPL) | These highlights do not include all the information needed to use ZIAGEN safely and effectively. See full prescribing information for ZIAGEN.ZIAGEN (abacavir sulfate) Tablets, for oral useZIAGEN (abacavir sulfate) Oral SolutionInitial U.S. Approval: 1998 | prescription | Human Prescription | Remedyrepack Inc. | 2013-04-08 | 1 | 493490905 | ||
| 10 | d4c622c8-73ba-49b4-9ac5-81bf87702775 (view SPL) | These highlights do not include all the information needed to use abacavir tablets safely and effectively. See full prescribing information for abacavir tablets. Abacavir Tablets, USP for Oral UseInitial U.S. Approval: 1998 | prescription | Human Prescription | Remedyrepack Inc. | 2013-02-27 | 2 | 493490999 | ||
| 11 | e3961e38-20d5-4014-a9d5-1ab13611abb9 (view SPL) | These highlights do not include all the information needed to use abacavir tablets safely and effectively. See full prescribing information for abacavir tablets. Abacavir Tablets, USP for Oral UseInitial U.S. Approval: 1998 | prescription | Human Prescription | State Of Florida Doh Central Pharmacy | repack | 2013-08-08 | 1 | 538080627 | |
| 12 | ff62bcaa-a200-4ebf-a9ca-1ab2c254751c (view SPL) | These highlights do not include all the information needed to use ZIAGEN safely and effectively. See full prescribing information for ZIAGEN.ZIAGEN (abacavir sulfate) Tablets and Oral SolutionInitial U.S. Approval: 1998 | prescription | Human Prescription | State Of Florida Doh Central Pharmacy | repack | 2010-04-13 | 1 | 538080811 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII