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 1.

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 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078150-002	GABAPENTIN	300MG	CAPSULE / ORAL	2007-09-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078150-003	GABAPENTIN	400MG	CAPSULE / ORAL	2007-09-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078150-001	GABAPENTIN	100MG	CAPSULE / ORAL	2007-09-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078150-002	GABAPENTIN	300MG	CAPSULE / ORAL	2007-09-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078150-003	GABAPENTIN	400MG	CAPSULE / ORAL	2007-09-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078150-001	GABAPENTIN	100MG	CAPSULE / ORAL	2007-09-25	`8072bd15b7f6…`

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 21 · 410 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	ddb3a54f-5224-4024-8804-b2a2f01d885e	2026-08-06	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	fce0c123-29d7-42bf-8c8d-8be1772e2d99	2026-08-06	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Redpharm Drug	58474aa7-7c6a-3a94-e063-6394a90a870b	2026-08-05	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Coupler LLC	583ab038-7b6e-96f8-e063-6294a90adf47	2026-08-04	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	e877a425-2b7f-4e43-a1f9-24019cbf9685	2026-07-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	TIME CAP LABORATORIES, INC	08880902-bd44-41b6-866b-2cbad4c3f2b1	2026-07-30	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	81243958-cc5a-4ec0-a64d-71682f949d5f	2026-07-30	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	bc525ae4-9843-4038-a1b7-0d3543e2282c	2026-07-30	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Cardinal Health 107, LLC	934244c6-243d-436e-ad6c-f7bd28e45a86	2026-07-28	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	TAGI Pharma, Inc.	725878fa-1e2f-4fee-a9e1-a6e102c79625	2026-07-28	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Ascend Laboratories, LLC	722de2a9-38b3-4518-b262-ba0d1346d0ba	2026-07-24	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	5a78ab50-993d-4857-be10-be665e02b353	2026-07-23	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	429a1bb5-babf-4f36-8264-46d71164f1c0	2026-07-22	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	NuCare Pharmaceuticals, Inc.	57383d2a-d2c7-bbdc-e063-6294a90ada98	2026-07-22	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	ScieGen Pharmaceuticals, Inc.	16542ee6-0e0e-4d3c-8b32-60ff6ef48846	2026-07-21	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
gabapentin	GABAPENTIN	REMEDYREPACK INC.	32169228-e85c-4dbf-8722-cd2f8e0f5d1a	2026-07-20	Warnings, Adverse reactions	Name fallback brand name: gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	St. Mary's Medical Park Pharmacy	57492b91-1fe2-74ab-e063-6394a90a0b9e	2026-07-20	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	07c8bb17-9bd4-4fab-994d-0412205b53b4	2026-07-17	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	PD-Rx Pharmaceuticals, Inc.	4a95f18e-0de4-4ce1-9f97-bc2e8a5bac6a	2026-07-17	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	St. Mary's Medical Park Pharmacy	3c585b71-5cfc-18d6-e063-6294a90a3dcf	2026-07-17	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN

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