Application 078150

Type: ANDA
Sponsor: HIKMA

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
A078150-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	2007-09-25
A078150-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	2007-09-25
A078150-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	2007-09-25

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078150-001	GABAPENTIN	100MG	CAPSULE / ORAL	2007-09-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078150-002	GABAPENTIN	300MG	CAPSULE / ORAL	2007-09-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078150-003	GABAPENTIN	400MG	CAPSULE / ORAL	2007-09-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078150-001	GABAPENTIN	100MG	CAPSULE / ORAL	2007-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078150-002	GABAPENTIN	300MG	CAPSULE / ORAL	2007-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078150-003	GABAPENTIN	400MG	CAPSULE / ORAL	2007-09-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078150-001	GABAPENTIN	100MG	CAPSULE / ORAL	2007-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078150-002	GABAPENTIN	300MG	CAPSULE / ORAL	2007-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078150-003	GABAPENTIN	400MG	CAPSULE / ORAL	2007-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078150-001	GABAPENTIN	100MG	CAPSULE / ORAL	2007-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078150-002	GABAPENTIN	300MG	CAPSULE / ORAL	2007-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078150-003	GABAPENTIN	400MG	CAPSULE / ORAL	2007-09-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078150-001	GABAPENTIN	100MG	CAPSULE / ORAL	2007-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078150-002	GABAPENTIN	300MG	CAPSULE / ORAL	2007-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078150-003	GABAPENTIN	400MG	CAPSULE / ORAL	2007-09-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078150-001	GABAPENTIN	100MG	CAPSULE / ORAL	2007-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078150-002	GABAPENTIN	300MG	CAPSULE / ORAL	2007-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078150-003	GABAPENTIN	400MG	CAPSULE / ORAL	2007-09-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078150-001	GABAPENTIN	100MG	CAPSULE / ORAL	2007-09-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078150-002	GABAPENTIN	300MG	CAPSULE / ORAL	2007-09-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078150-003	GABAPENTIN	400MG	CAPSULE / ORAL	2007-09-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078150-001	GABAPENTIN	100MG	CAPSULE / ORAL	2007-09-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078150-002	GABAPENTIN	300MG	CAPSULE / ORAL	2007-09-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078150-003	GABAPENTIN	400MG	CAPSULE / ORAL	2007-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078150-001	GABAPENTIN	100MG	CAPSULE / ORAL	2007-09-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078150-002	GABAPENTIN	300MG	CAPSULE / ORAL	2007-09-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078150-003	GABAPENTIN	400MG	CAPSULE / ORAL	2007-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078150-001	GABAPENTIN	100MG	CAPSULE / ORAL	2007-09-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078150-002	GABAPENTIN	300MG	CAPSULE / ORAL	2007-09-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078150-003	GABAPENTIN	400MG	CAPSULE / ORAL	2007-09-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078150-001	GABAPENTIN	100MG	CAPSULE / ORAL	2007-09-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078150-002	GABAPENTIN	300MG	CAPSULE / ORAL	2007-09-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078150-003	GABAPENTIN	400MG	CAPSULE / ORAL	2007-09-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078150-001	GABAPENTIN	100MG	CAPSULE / ORAL	2007-09-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078150-002	GABAPENTIN	300MG	CAPSULE / ORAL	2007-09-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078150-003	GABAPENTIN	400MG	CAPSULE / ORAL	2007-09-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078150-001	GABAPENTIN	100MG	CAPSULE / ORAL	2007-09-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078150-002	GABAPENTIN	300MG	CAPSULE / ORAL	2007-09-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078150-003	GABAPENTIN	400MG	CAPSULE / ORAL	2007-09-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078150-001	GABAPENTIN	100MG	CAPSULE / ORAL	2007-09-25	`301d65b070ca…`

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 16 of 21 · 402 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	657349fb-41a9-4814-b4ac-4c5afbdde947	2024-10-30	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	a15d5dcc-63c4-4c06-ab91-5e22cdf234cc	2024-10-30	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	477691f5-0591-4544-840a-ac590e1f25a1	2024-10-30	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	506bf880-9564-404c-951a-703797ffdad8	2024-10-29	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	77754734-4125-42b1-97c8-458bcab2bcf1	2024-10-23	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	fb0b6613-57d6-4e24-946f-f5f87c460cf0	2024-10-18	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	ef37f2a0-3b83-4f71-91c0-6435161b483c	2024-10-18	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	ff28c5f1-da56-4072-a6fa-d689d4a6761b	2024-10-07	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Direct_Rx	fbc05ceb-2e69-3c37-e053-6394a90ac4f4	2024-09-06	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	2dad630a-09d8-4f40-bdad-24e877a9ee38	2024-09-03	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Creekwood Pharmaceuticals LLC	26aac429-a5cd-33cc-e063-6394a90aecc0	2024-09-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Creekwood Pharmaceuticals LLC	266ef369-0a56-f225-e063-6294a90a495e	2024-09-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	1e28ad3d-2d34-a5d0-e063-6294a90adb9e	2024-07-26	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	NuCare Pharmaceuticals,Inc.	a9c99dfa-f54d-9207-e053-2995a90ad43b	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	NuCare Pharmaceuticals,Inc.	a9f0852e-0c58-ba22-e053-2995a90adfa0	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	6e6b9d8f-9f9e-4760-96ea-fb8b0a3bbbdb	2024-07-08	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	NuCare Pharmaceuticals,Inc.	8f785189-bf66-36cc-e053-2a95a90a7cbc	2024-06-19		Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	NuCare Pharmaceuticals,Inc.	8e6ed5d2-40e0-1f06-e053-2a95a90aa40e	2024-06-18	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	NuCare Pharmaceuticals,Inc.	82c0ed15-9132-657d-e053-2991aa0ae90a	2024-06-14		Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	ffe5321d-3405-46d5-a75f-c51e8f8d87b1	2024-05-29	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 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-3991	Gabapentin	Gabapentin	West-ward Pharmaceutical Corp	ANDA	Current
0143-3993	Gabapentin	Gabapentin	West-ward Pharmaceutical Corp	ANDA	Current
0143-3994	Gabapentin	Gabapentin	West-ward Pharmaceutical Corp	ANDA	Current
0143-9992	Gabapentin	Gabapentin	West-ward Pharmaceutical Corp	ANDA	Current
0143-9993	Gabapentin	Gabapentin	West-ward Pharmaceutical Corp	ANDA	Current
0143-9994	Gabapentin	Gabapentin	West-ward Pharmaceutical Corp	ANDA	Current
59115-073	Gabapentin	Gabapentin	Hikma Pharmaceutical	ANDA	Current
59115-073	Gabapentin	Gabapentin	Hikma Pharmaceutical	ANDA	Current
59115-074	Gabapentin	Gabapentin	Hikma Pharmaceutical	ANDA	Current
59115-074	Gabapentin	Gabapentin	Hikma Pharmaceutical	ANDA	Current
59115-075	Gabapentin	Gabapentin	Hikma Pharmaceutical	ANDA	Current
59115-075	Gabapentin	Gabapentin	Hikma Pharmaceutical	ANDA	Current
66336-439	Gabapentin	Gabapentin	Dispensing Solutions, Inc.	ANDA	Current
66336-567	Gabapentin	Gabapentin	Dispensing Solutions, Inc.	ANDA	Current