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 14 of 21 · 402 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GABAPENTIN	GABAPENTIN	DIRECT RX	a7e45e3f-e382-32ba-e053-2a95a90a2537	2025-01-17		Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Clinical Solutions Wholesale, LLC	743faa18-5e7c-4fcc-9781-4157450d90c4	2025-01-16	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	NuCare Pharmaceuticals,Inc.	bd5c9279-a1e3-2a59-e053-2a95a90a33a2	2025-01-14	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	41ce952c-6c16-4b5d-adf7-9ea114e63eb3	2025-01-09	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	13b87441-8fe1-40f5-8ffb-00dcd8cc90a6	2025-01-09	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	AvPAK	faa47fcd-2545-a946-e053-6294a90a05d2	2025-01-09	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	95757436-2093-41cf-a9a9-ef2f28ac096f	2025-01-09	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	NuCare Pharmaceuticals,Inc.	2b395a14-0f8e-7f5b-e063-6294a90ab546	2025-01-08	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Advanced Rx of Tennessee, LLC	afa28969-91ca-83fd-e053-2a95a90a656b	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Advanced Rx of Tennessee, LLC	afa28969-91c8-83fd-e053-2a95a90a656b	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	ADVANCED RX OF TENNESSEE, LLC	af73fbd8-9731-e6bf-e053-2995a90af65d	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Advanced Rx of Tennessee, LLC	afc80b8b-da39-6fb9-e053-2a95a90a2d8e	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Advanced Rx of Tennessee, LLC	b062f12c-a745-76d4-e053-2a95a90a3a1a	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Advanced Rx of Tennessee, LLC	b33c18ea-554d-3cfb-e053-2a95a90a2dd1	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Advanced Rx of Tennessee, LLC	b37b1dcc-c7e9-8845-e053-2995a90a089e	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Advanced Rx Pharmacy of Tennessee, LLC	c898711b-9a65-1816-e053-2995a90a855e	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Advanced Rx of Tennessee, LLC	d294f6aa-ed82-90a2-e053-2995a90a2896	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Advanced Rx Pharmacy of Tennessee, LLC	ec1c621b-db2a-1567-e053-2995a90a8695	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Advanced Rx Pharmacy of Tennessee, LLC	c89a68b6-6dc0-4624-e053-2a95a90a687e	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Advanced Rx Pharmacy of Tennessee, LLC	bc08e35d-ef5d-1dcd-e053-2a95a90ab5de	2024-12-31	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