Application 076672

Type: ANDA
Sponsor: TARO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GABAPENTIN	GABAPENTIN	SOLUTION;ORAL	250MG/5ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A076672-001	GABAPENTIN	GABAPENTIN	250MG/5ML	SOLUTION / ORAL			2013-07-03

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 · 43 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
2026-09-14 22:38:34	2026-08	A076672-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL		2013-07-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076672-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL		2013-07-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076672-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL		2013-07-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076672-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL		2013-07-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076672-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2013-07-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076672-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2013-07-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076672-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2013-07-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076672-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2013-07-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076672-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2013-07-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076672-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2013-07-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076672-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2013-07-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076672-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2013-07-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076672-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2013-07-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076672-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2013-07-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076672-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2013-07-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076672-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2013-07-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076672-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2013-07-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076672-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2013-07-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076672-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2013-07-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076672-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2013-07-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076672-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2013-07-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076672-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2013-07-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076672-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2013-07-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076672-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2013-07-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076672-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2013-07-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076672-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2013-07-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076672-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2013-07-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076672-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2013-07-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076672-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2013-07-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076672-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2013-07-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076672-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2013-07-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076672-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2013-07-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076672-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2013-07-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076672-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2013-07-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076672-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2013-07-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076672-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2013-07-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076672-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2013-07-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076672-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2013-07-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076672-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2013-07-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076672-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2013-07-03	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A076672-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076672-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076672-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076672-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076672-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076672-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076672-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076672-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076672-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076672-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076672-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076672-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076672-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076672-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076672-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076672-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076672-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076672-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076672-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076672-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076672-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076672-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076672-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076672-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076672-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076672-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076672-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076672-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076672-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076672-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076672-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076672-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076672-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076672-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076672-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076672-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076672-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076672-001	AA	1	`cb3db0bc1861…`

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 20 of 20 · 394 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GABAPENTIN	GABAPENTIN	Proficient Rx LP	92c4d589-533b-4fe4-833f-dd68cc1f7e66	2019-11-01	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Proficient Rx LP	2ef99c3d-866a-438b-a340-8beba8d4c457	2019-11-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Proficient Rx LP	c78f528f-9192-4037-bfb9-ff5718ed26c5	2019-10-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Epic Pharma, LLC	030e656a-e384-49ac-830f-32140c18112d	2019-01-07	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	a900bafb-8f49-4a01-ba7f-4fb228ec0253	2018-11-12	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	6702ed8f-4aaf-46fa-bf39-db75154aa44c	2018-10-19	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	1b73e9db-eddb-49ba-9778-01d39ece4d16	2018-09-21	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	f455b415-12a2-4916-b826-246976a8af44	2018-09-12	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	5fbd601f-df95-4a79-a7d3-c3505e23b913	2018-09-06	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	9d1b9121-c25a-4d28-91c5-5fc72f1167f4	2018-07-12		Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	37d4d465-19a5-46db-80dc-0b7334b3343a	2018-06-25	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	6fc8e8b2-5d0e-4c72-9a46-6d312c3efac7	2018-05-14	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	86b30e64-fe56-42b3-a0f8-d9ef5d4b8c49	2016-06-20	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bi-Coastal Pharma International LLC	e0cd96d1-b1ef-46ec-a5a3-9505b0811b8b	2016-04-17	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51672-4075	Gabapentin	Gabapentin	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current