Application 091294

Type: ANDA
Sponsor: MYLAN PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ABACAVIR SULFATE	ABACAVIR SULFATE	TABLET;ORAL	EQ 300MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091294-001	ABACAVIR SULFATE	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB		2012-06-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A091294-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A091294-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-06-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091294-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-06-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091294-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-06-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091294-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-06-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091294-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-06-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091294-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-06-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091294-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-06-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091294-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-06-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091294-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-06-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091294-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-06-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091294-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-06-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091294-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-06-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091294-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-06-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091294-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-06-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091294-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-06-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091294-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-06-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091294-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-06-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091294-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-06-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091294-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-06-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091294-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-06-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091294-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-06-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091294-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-06-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091294-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-06-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091294-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-06-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091294-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-06-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091294-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-06-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091294-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-06-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091294-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-06-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091294-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-06-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091294-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-06-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091294-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-06-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091294-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-06-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091294-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-06-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091294-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-06-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091294-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-06-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091294-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-06-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091294-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-06-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091294-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-06-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091294-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-06-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091294-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-06-18	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A091294-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091294-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091294-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091294-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091294-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091294-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091294-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091294-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091294-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091294-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091294-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091294-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091294-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091294-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091294-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091294-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091294-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091294-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091294-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091294-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091294-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091294-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091294-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091294-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091294-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091294-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091294-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091294-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091294-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091294-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091294-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091294-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091294-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091294-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091294-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091294-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091294-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091294-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091294-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091294-001	AB	1	`e64feba35796…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Abacavir Sulfate	ABACAVIR SULFATE	Safecor Health, LLC	f7633480-25aa-4326-bec9-82835b486a20	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091294 application number: ANDA091294
Abacavir Sulfate	ABACAVIR SULFATE	Mylan Institutional Inc.	80c1702a-973c-436a-90f8-69b29674dca0	2025-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091294 application number: ANDA091294 ndc (product): 51079-204
Abacavir Sulfate	ABACAVIR SULFATE	Mylan Pharmaceuticals Inc.	5676d391-f9a4-44be-9604-954b3d8d0e2b	2021-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091294 application number: ANDA091294 ndc (product): 0378-4105

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-4105	Abacavir Sulfate	abacavir sulfate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4105	Abacavir Sulfate	abacavir sulfate	Mylan Pharmaceuticals Inc.	ANDA	Current
51079-204	Abacavir Sulfate	abacavir sulfate	Mylan Institutional Inc.	ANDA	Current
51079-204	Abacavir Sulfate	abacavir sulfate	Mylan Institutional Inc.	ANDA	Current
51079-204	Abacavir Sulfate	abacavir sulfate	Mylan Institutional Inc.	ANDA	Current
51079-204	Abacavir Sulfate	abacavir sulfate	Mylan Institutional Inc.	ANDA	Current
53808-0627	Abacavir Sulfate	abacavir sulfate	State of Florida DOH Central Pharmacy	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
62198	ORIG	2020-03-19
31523	ORIG	2012-06-20