Application 206943

Type: ANDA
Sponsor: ACI HEALTHCARE LTD

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	TE codes	Approval date
A206943-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-05-14
A206943-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-05-14
A206943-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-05-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A206943-001	AB
A206943-002	AB
A206943-003	AB

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	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A206943-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-05-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206943-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-05-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206943-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-05-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206943-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-05-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206943-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-05-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206943-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-05-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206943-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-05-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206943-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-05-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206943-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-05-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206943-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-05-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206943-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-05-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206943-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-05-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206943-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-05-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206943-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-05-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206943-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-05-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206943-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-05-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206943-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-05-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206943-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-05-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206943-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-05-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206943-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-05-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206943-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-05-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206943-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-05-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206943-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-05-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206943-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-05-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206943-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-05-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206943-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-05-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206943-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-05-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206943-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-05-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206943-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-05-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206943-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-05-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206943-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-05-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206943-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-05-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206943-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-05-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206943-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-05-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206943-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-05-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206943-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-05-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206943-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-05-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206943-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-05-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206943-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-05-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206943-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-05-14	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A206943-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206943-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206943-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206943-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206943-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206943-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206943-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206943-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206943-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206943-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206943-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206943-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206943-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206943-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206943-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206943-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206943-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206943-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206943-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206943-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206943-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206943-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206943-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206943-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206943-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206943-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206943-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206943-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206943-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206943-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206943-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206943-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206943-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206943-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206943-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206943-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206943-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206943-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206943-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206943-001	AB	1	`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 2 of 2 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	1ec656c9-034f-4f14-9e6b-9779d41e1627	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206943 application number: ANDA206943 ndc (product): 71335-1348
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	8de89818-805a-4a20-a9b1-48cf443b6315	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206943 application number: ANDA206943 ndc (product): 71335-1169
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	9efd0261-9fc9-4dc9-8cf3-9110157ddfc4	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206943 application number: ANDA206943
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	01b810b7-f4c8-4412-bbc5-b9220d8770d8	2024-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206943 application number: ANDA206943 ndc (product): 71335-1093
Gabapentin	GABAPENTIN	Medsource Pharmaceuticals	1278512b-1493-db65-e063-6394a90ab161	2024-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206943 application number: ANDA206943
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	e286ed87-5fbc-4ff2-a05e-1f7fa658bbfc	2023-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206943 application number: ANDA206943
Gabapentin	GABAPENTIN	Proficient Rx LP	645824d0-eb3d-442b-806d-36a70796cb8e	2022-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206943 application number: ANDA206943 ndc (product): 71205-317

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 · 70 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-4889	Gabapentin	Gabapentin	A-S Medication Solutions	ANDA	Current
50090-4889	Gabapentin	Gabapentin	A-S Medication Solutions	ANDA	Current
60760-814	Gabapentin	Gabapentin	St Mary's Medical Park Pharmacy	ANDA	Current
63629-8059	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
63629-8059	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
63629-8059	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
67296-1709	Gabapentin	Gabapentin	RedPharm Drug, Inc.	ANDA	Current
67296-1709	Gabapentin	Gabapentin	RedPharm Drug, Inc.	ANDA	Current
68071-2876	Gabapentin	Gabapentin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2883	Gabapentin	Gabapentin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2883	Gabapentin	Gabapentin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4978	Gabapentin	Gabapentin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4978	Gabapentin	Gabapentin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4978	Gabapentin	Gabapentin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7431	Gabapentin	Gabapentin	Preferred Pharmaceuticals, Inc.791119022	ANDA	Current
68788-7431	Gabapentin	Gabapentin	Preferred Pharmaceuticals, Inc.791119022	ANDA	Current
68788-7431	Gabapentin	Gabapentin	Preferred Pharmaceuticals, Inc.791119022	ANDA	Current
68788-7444	Gabapentin	Gabapentin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7444	Gabapentin	Gabapentin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7444	Gabapentin	Gabapentin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7614	Gabapentin	Gabapentin	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7614	Gabapentin	Gabapentin	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8194	Gabapentin	Gabapentin	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8199	Gabapentin	Gabapentin	Preferred Pharmaceuticals Inc.	ANDA	Current
71093-120	Gabapentin	Gabapentin	ACI Healthcare USA, Inc.	ANDA	Current
71093-120	Gabapentin	Gabapentin	ACI Healthcare USA, Inc.	ANDA	Current
71093-120	Gabapentin	Gabapentin	ACI Healthcare USA, Inc.	ANDA	Current
71093-120	Gabapentin	Gabapentin	ACI Healthcare USA, Inc.	ANDA	Current
71093-120	Gabapentin	Gabapentin	ACI Healthcare USA, Inc.	ANDA	Current
71093-120	Gabapentin	Gabapentin	ACI Healthcare USA, Inc.	ANDA	Current
71093-121	Gabapentin	Gabapentin	ACI Healthcare USA, Inc.	ANDA	Current
71093-121	Gabapentin	Gabapentin	ACI Healthcare USA, Inc.	ANDA	Current
71093-121	Gabapentin	Gabapentin	ACI Healthcare USA, Inc.	ANDA	Current
71093-121	Gabapentin	Gabapentin	ACI Healthcare USA, Inc.	ANDA	Current
71093-121	Gabapentin	Gabapentin	ACI Healthcare USA, Inc.	ANDA	Current
71093-121	Gabapentin	Gabapentin	ACI Healthcare USA, Inc.	ANDA	Current
71093-122	Gabapentin	Gabapentin	ACI Healthcare USA, Inc.	ANDA	Current
71093-122	Gabapentin	Gabapentin	ACI Healthcare USA, Inc.	ANDA	Current
71093-122	Gabapentin	Gabapentin	ACI Healthcare USA, Inc.	ANDA	Current
71093-122	Gabapentin	Gabapentin	ACI Healthcare USA, Inc.	ANDA	Current
71093-122	Gabapentin	Gabapentin	ACI Healthcare USA, Inc.	ANDA	Current
71093-122	Gabapentin	Gabapentin	ACI Healthcare USA, Inc.	ANDA	Current
71205-317	Gabapentin	Gabapentin	Proficient Rx LP	ANDA	Current
71205-317	Gabapentin	Gabapentin	Proficient Rx LP	ANDA	Current
71205-317	Gabapentin	Gabapentin	Proficient Rx LP	ANDA	Current
71335-1093	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-1093	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-1093	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-1093	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-1169	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-1169	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-1169	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-1169	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-1313	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-1313	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-1313	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-1323	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-1323	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-1323	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-1323	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-1348	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-1348	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-1375	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-1375	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-1375	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-1497	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-1497	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-1641	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
80425-0031	Gabapentin	Gabapentin	ADVANCED RX PHARMACY OF TENNESSEE, LLC	ANDA	Current
80425-0031	Gabapentin	Gabapentin	ADVANCED RX PHARMACY OF TENNESSEE, LLC	ANDA	Current