Application 213603

Type: ANDA
Sponsor: ZHEJIANG YONGTAI

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
A213603-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17
A213603-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17
A213603-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213603-001	AB
A213603-002	AB
A213603-003	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 3 · 117 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	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 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	A213603-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213603-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213603-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213603-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213603-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213603-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213603-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213603-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213603-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213603-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213603-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213603-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213603-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213603-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213603-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213603-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213603-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213603-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213603-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213603-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213603-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213603-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213603-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213603-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213603-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213603-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213603-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213603-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213603-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213603-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213603-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213603-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213603-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213603-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213603-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213603-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213603-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213603-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213603-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213603-001	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 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Zhejiang Yongtai Pharmaceutical Co., Ltd	f1eda6cc-d9b2-4df4-a09b-20eebded760f	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213603 application number: ANDA213603 ndc (product): 69434-042 ndc (product): 69434-044 ndc (product): 69434-043
Gabapentin	GABAPENTIN	Direct_Rx	e90d2e3d-ec86-7d1d-e053-2995a90a9167	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213603 application number: ANDA213603 ndc (product): 72189-384
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	2dad630a-09d8-4f40-bdad-24e877a9ee38	2024-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213603 application number: ANDA213603
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	ffe5321d-3405-46d5-a75f-c51e8f8d87b1	2024-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213603 application number: ANDA213603

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 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69434-042	Gabapentin	Gabapentin	Zhejiang Yongtai Pharmaceutical Co., Ltd.	ANDA	Current
69434-043	Gabapentin	Gabapentin	Zhejiang Yongtai Pharmaceutical Co., Ltd.	ANDA	Current
69434-044	Gabapentin	Gabapentin	Zhejiang Yongtai Pharmaceutical Co., Ltd.	ANDA	Current
71093-161	Gabapentin	Gabapentin	ACI Healthcare USA, Inc.	ANDA	Current
71093-161	Gabapentin	Gabapentin	ACI Healthcare USA, Inc.	ANDA	Current
71093-161	Gabapentin	Gabapentin	ACI Healthcare USA, Inc.	ANDA	Current
71093-161	Gabapentin	Gabapentin	ACI Healthcare USA, Inc.	ANDA	Current
71093-161	Gabapentin	Gabapentin	ACI Healthcare USA, Inc.	ANDA	Current
71093-161	Gabapentin	Gabapentin	ACI Healthcare USA, Inc.	ANDA	Current
71093-162	Gabapentin	Gabapentin	ACI Healthcare USA, Inc.	ANDA	Current
71093-162	Gabapentin	Gabapentin	ACI Healthcare USA, Inc.	ANDA	Current
71093-162	Gabapentin	Gabapentin	ACI Healthcare USA, Inc.	ANDA	Current
71093-162	Gabapentin	Gabapentin	ACI Healthcare USA, Inc.	ANDA	Current
71093-162	Gabapentin	Gabapentin	ACI Healthcare USA, Inc.	ANDA	Current
71093-162	Gabapentin	Gabapentin	ACI Healthcare USA, Inc.	ANDA	Current
71093-163	Gabapentin	Gabapentin	ACI Healthcare USA, Inc.	ANDA	Current
71093-163	Gabapentin	Gabapentin	ACI Healthcare USA, Inc.	ANDA	Current
71093-163	Gabapentin	Gabapentin	ACI Healthcare USA, Inc.	ANDA	Current
71093-163	Gabapentin	Gabapentin	ACI Healthcare USA, Inc.	ANDA	Current
71093-163	Gabapentin	Gabapentin	ACI Healthcare USA, Inc.	ANDA	Current
71093-163	Gabapentin	Gabapentin	ACI Healthcare USA, Inc.	ANDA	Current
72189-384	Gabapentin	Gabapentin	Direct_Rx	ANDA	Current
72189-384	Gabapentin	Gabapentin	Direct_Rx	ANDA	Current