Application 216067

Type: ANDA
Sponsor: ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NIFEDIPINE	NIFEDIPINE	TABLET, EXTENDED RELEASE;ORAL	30MG	No	No
002	NIFEDIPINE	NIFEDIPINE	TABLET, EXTENDED RELEASE;ORAL	60MG	No	No
003	NIFEDIPINE	NIFEDIPINE	TABLET, EXTENDED RELEASE;ORAL	90MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A216067-001	NIFEDIPINE	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29
A216067-002	NIFEDIPINE	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29
A216067-003	NIFEDIPINE	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216067-001	AB2
A216067-002	AB2
A216067-003	AB2

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 · 93 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
2026-08-18 06:07:40	2026-07	A216067-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216067-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216067-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216067-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216067-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216067-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216067-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216067-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216067-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216067-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216067-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216067-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216067-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216067-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216067-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216067-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216067-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216067-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216067-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216067-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216067-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216067-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216067-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216067-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216067-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216067-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216067-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216067-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216067-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216067-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216067-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216067-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216067-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216067-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216067-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216067-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216067-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216067-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216067-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216067-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 93 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A216067-001	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216067-002	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216067-003	AB2	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216067-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216067-002	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216067-003	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216067-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216067-002	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216067-003	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216067-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216067-002	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216067-003	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216067-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216067-002	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216067-003	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216067-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216067-002	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216067-003	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216067-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216067-002	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216067-003	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216067-001	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216067-002	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216067-003	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216067-001	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216067-002	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216067-003	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216067-001	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216067-002	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216067-003	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216067-001	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216067-002	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216067-003	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216067-001	AB2	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216067-002	AB2	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216067-003	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216067-001	AB2	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216067-002	AB2	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216067-003	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216067-001	AB2	1	`1e350fbaab3a…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nifedipine	NIFEDIPINE	PD-Rx Pharmaceuticals, Inc.	7160331a-8735-4bc0-8cb9-a8014512a669	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216067 application number: ANDA216067
Nifedipine	NIFEDIPINE	PD-Rx Pharmaceuticals, Inc.	89723620-474e-4b16-9f57-4e927efc401c	2026-01-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216067 application number: ANDA216067
Nifedipine	NIFEDIPINE	PD-Rx Pharmaceuticals, Inc.	8e5e126a-7da6-4ceb-b72b-5c9dcc7d7769	2026-01-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216067 application number: ANDA216067
Nifedipine	NIFEDIPINE	A-S Medication Solutions	5a7951e7-f507-43e8-9bba-855b79daf170	2026-01-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216067 application number: ANDA216067
Nifedipine	NIFEDIPINE	Redpharm Drug	32526983-f53a-fa68-e063-6394a90aa13f	2025-12-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216067 application number: ANDA216067
Nifedipine	NIFEDIPINE	Ascend Laboratories, LLC	f661c1d9-f0f6-4595-82dd-f656bff974f1	2025-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216067 application number: ANDA216067 ndc (product): 67877-758 ndc (product): 67877-756 ndc (product): 67877-757
Nifedipine	NIFEDIPINE	A-S Medication Solutions	4a4d5b67-6ce7-4098-9324-f68084e800e4	2023-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216067 application number: ANDA216067

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67877-756	Nifedipine	Nifedipine	Ascend Laboratories, LLC	ANDA	Current
67877-756	Nifedipine	Nifedipine	Ascend Laboratories, LLC	ANDA	Current
67877-757	Nifedipine	Nifedipine	Ascend Laboratories, LLC	ANDA	Current
67877-757	Nifedipine	Nifedipine	Ascend Laboratories, LLC	ANDA	Current
67877-758	Nifedipine	Nifedipine	Ascend Laboratories, LLC	ANDA	Current
67877-758	Nifedipine	Nifedipine	Ascend Laboratories, LLC	ANDA	Current