Application 075435

Type: ANDA
Sponsor: TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GABAPENTIN	GABAPENTIN	CAPSULE;ORAL	100MG	No	No
002	GABAPENTIN	GABAPENTIN	CAPSULE;ORAL	300MG	No	No
003	GABAPENTIN	GABAPENTIN	CAPSULE;ORAL	400MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A075435-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	2004-10-08
A075435-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	2004-10-08
A075435-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	2004-10-08

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 2 of 4 · 129 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
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075435-002	GABAPENTIN	300MG	CAPSULE / ORAL		2004-10-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075435-003	GABAPENTIN	400MG	CAPSULE / ORAL		2004-10-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075435-001	GABAPENTIN	100MG	CAPSULE / ORAL		2004-10-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075435-002	GABAPENTIN	300MG	CAPSULE / ORAL		2004-10-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075435-003	GABAPENTIN	400MG	CAPSULE / ORAL		2004-10-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075435-001	GABAPENTIN	100MG	CAPSULE / ORAL		2004-10-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075435-002	GABAPENTIN	300MG	CAPSULE / ORAL		2004-10-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075435-003	GABAPENTIN	400MG	CAPSULE / ORAL		2004-10-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075435-001	GABAPENTIN	100MG	CAPSULE / ORAL		2004-10-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075435-002	GABAPENTIN	300MG	CAPSULE / ORAL		2004-10-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075435-003	GABAPENTIN	400MG	CAPSULE / ORAL		2004-10-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075435-001	GABAPENTIN	100MG	CAPSULE / ORAL		2004-10-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075435-002	GABAPENTIN	300MG	CAPSULE / ORAL		2004-10-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075435-003	GABAPENTIN	400MG	CAPSULE / ORAL		2004-10-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075435-001	GABAPENTIN	100MG	CAPSULE / ORAL		2004-10-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075435-002	GABAPENTIN	300MG	CAPSULE / ORAL		2004-10-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075435-003	GABAPENTIN	400MG	CAPSULE / ORAL		2004-10-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075435-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2004-10-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075435-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2004-10-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075435-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2004-10-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075435-001	GABAPENTIN	100MG	CAPSULE / ORAL		2004-10-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075435-002	GABAPENTIN	300MG	CAPSULE / ORAL		2004-10-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075435-003	GABAPENTIN	400MG	CAPSULE / ORAL		2004-10-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075435-001	GABAPENTIN	100MG	CAPSULE / ORAL		2004-10-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075435-002	GABAPENTIN	300MG	CAPSULE / ORAL		2004-10-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075435-003	GABAPENTIN	400MG	CAPSULE / ORAL		2004-10-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075435-001	GABAPENTIN	100MG	CAPSULE / ORAL		2004-10-08	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075435-002	GABAPENTIN	300MG	CAPSULE / ORAL		2004-10-08	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075435-003	GABAPENTIN	400MG	CAPSULE / ORAL		2004-10-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075435-001	GABAPENTIN	100MG	CAPSULE / ORAL		2004-10-08	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075435-002	GABAPENTIN	300MG	CAPSULE / ORAL		2004-10-08	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075435-003	GABAPENTIN	400MG	CAPSULE / ORAL		2004-10-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075435-001	GABAPENTIN	100MG	CAPSULE / ORAL		2004-10-08	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075435-002	GABAPENTIN	300MG	CAPSULE / ORAL		2004-10-08	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075435-003	GABAPENTIN	400MG	CAPSULE / ORAL		2004-10-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075435-001	GABAPENTIN	100MG	CAPSULE / ORAL		2004-10-08	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075435-002	GABAPENTIN	300MG	CAPSULE / ORAL		2004-10-08	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075435-003	GABAPENTIN	400MG	CAPSULE / ORAL		2004-10-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075435-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2004-10-08	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075435-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2004-10-08	`3f01610625f2…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A075435-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075435-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075435-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A075435-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075435-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075435-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075435-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075435-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075435-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075435-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075435-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075435-003	AB	1	`ea99ee380514…`

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 20 · 394 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
gabapentin	GABAPENTIN	REMEDYREPACK INC.	4a975ebe-ae0a-446a-8a3d-2ca325e28f93	2026-09-11	Warnings, Adverse reactions	Name fallback brand name: gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	167d8b87-506c-4293-9579-563feaa71583	2026-09-10	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Clinical Solutions Wholesale, LLC	b7f9a106-52c6-49e4-acf5-8fb07761ba4f	2026-09-09	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	NuCare Pharmaceuticals,Inc.	d35cd5ac-5ed6-2405-e053-2995a90a6946	2026-09-03	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	PHOENIX RX LLC	5a85ea98-4211-54eb-e063-6294a90aff33	2026-09-02	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	REMEDYREPACK INC.	1373587e-807a-462a-bff6-8a7113ce9f0a	2026-09-01	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	78445dbf-c7cd-419f-a7be-72821e496628	2026-08-28	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	4615aaa7-73d4-4473-8f26-e7a982f8a166	2026-08-27	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	1af098ad-28b5-463f-8efa-24d70a77d64c	2026-08-26	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	9a2658d5-9b0e-4921-b4c5-4c89f1630d69	2026-08-26	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	43cbff48-8219-41ba-b67d-3ae4544b78bb	2026-08-26	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	4c22c3e6-2471-4b89-945b-f846c4d7884e	2026-08-25	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	d06380d0-c894-427e-b13e-5a8f9eb86a34	2026-08-21	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	7652adc6-1aad-4422-b85c-0c6b11c23b73	2026-08-21	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	f0e7a6c9-ae6c-4259-81ab-a37db54e3c80	2026-08-19	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
gabapentin	GABAPENTIN	NuCare Pharmaceuticals, Inc.	596eb696-7696-202e-e063-6394a90a2844	2026-08-19	Warnings, Adverse reactions	Name fallback brand name: gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	eb2f6784-e7be-41b6-871b-2c3c961664ab	2026-08-19	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	8a781649-3271-47a6-995f-50f91141a48a	2026-08-19	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	6670a64f-7f58-479f-b285-394abb753e2e	2026-08-19	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Coupler LLC	5954a330-c225-00bd-e063-6294a90a7581	2026-08-18	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
66116-444	Gabapentin	Gabapentin	MedVantx Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8669	ORIG	2004-10-08