Application 202987

Type: ANDA
Sponsor: NOVAST LABS

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 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	TE codes	RLD / RS	Approval date
A202987-001	NIFEDIPINE	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2016-08-25
A202987-002	NIFEDIPINE	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25
A202987-003	NIFEDIPINE	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202987-001	AB1
A202987-002	AB1
A202987-003	AB1

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202987-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2016-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202987-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202987-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202987-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2016-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202987-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202987-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202987-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2016-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202987-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202987-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202987-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2016-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202987-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202987-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202987-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2016-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202987-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202987-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202987-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2016-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202987-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202987-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202987-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2016-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202987-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202987-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202987-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2016-08-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202987-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202987-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202987-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2016-08-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202987-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202987-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202987-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2016-08-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202987-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202987-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202987-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2016-08-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202987-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202987-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202987-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2016-08-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202987-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202987-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202987-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2016-08-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202987-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202987-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202987-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2016-08-25	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202987-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202987-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202987-003	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202987-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202987-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202987-003	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202987-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202987-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202987-003	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202987-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202987-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202987-003	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202987-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202987-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202987-003	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202987-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202987-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202987-003	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202987-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202987-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202987-003	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202987-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202987-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202987-003	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202987-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202987-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202987-003	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202987-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202987-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202987-003	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202987-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202987-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202987-003	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202987-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202987-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202987-003	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202987-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202987-002	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202987-003	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202987-001	AB1	1	`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 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nifedipine	NIFEDIPINE	Golden State Medical Supply, Inc.	d9a501be-8523-3924-e053-2995a90a8569	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202987 application number: ANDA202987 ndc (product): 51407-622 ndc (product): 51407-624 ndc (product): 51407-623
Nifedipine	NIFEDIPINE	Ingenus Pharmaceuticals, LLC	4d02eba2-e964-4fa7-aaae-25949b5f0316	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202987 application number: ANDA202987 ndc (product): 50742-622 ndc (product): 50742-620 ndc (product): 50742-621
Nifedipine	NIFEDIPINE	Northwind Health Company, LLC	da80fa84-9336-082c-e053-2a95a90a8987	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202987 application number: ANDA202987
Nifedipine	NIFEDIPINE	Aphena Pharma Solutions - Tennessee, LLC	1b98b011-793c-ed92-e063-6294a90ac2bc	2024-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202987 application number: ANDA202987
Nifedipine	NIFEDIPINE	Aphena Pharma Solutions - Tennessee, LLC	75bb3a1f-3cb7-4450-8e59-27521a1ebc25	2023-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202987 application number: ANDA202987

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-4249	Nifedipine	nifedipine	A-S Medication Solutions	ANDA	Current
50090-4249	Nifedipine	nifedipine	A-S Medication Solutions	ANDA	Current
50090-4442	Nifedipine	nifedipine	A-S Medication Solutions	ANDA	Current
50090-4442	Nifedipine	nifedipine	A-S Medication Solutions	ANDA	Current
50742-620	Nifedipine	nifedipine	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-620	Nifedipine	nifedipine	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-620	Nifedipine	nifedipine	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-621	Nifedipine	nifedipine	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-621	Nifedipine	nifedipine	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-621	Nifedipine	nifedipine	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-622	Nifedipine	nifedipine	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-622	Nifedipine	nifedipine	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-622	Nifedipine	nifedipine	Ingenus Pharmaceuticals, LLC	ANDA	Current
51407-622	Nifedipine	nifedipine	Golden State Medical Supply, Inc.	ANDA	Current
51407-623	Nifedipine	nifedipine	Golden State Medical Supply, Inc.	ANDA	Current
51407-624	Nifedipine	nifedipine	Golden State Medical Supply, Inc.	ANDA	Current
53808-1118	Nifedipine	nifedipine	DOH CENTRAL PHARMACY	ANDA	Current
68071-4334	Nifedipine	nifedipine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4334	Nifedipine	nifedipine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4334	Nifedipine	nifedipine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4411	Nifedipine	nifedipine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4411	Nifedipine	nifedipine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4411	Nifedipine	nifedipine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4558	Nifedipine	nifedipine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4558	Nifedipine	nifedipine	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-2089	Nifedipine	nifedipine	REMEDYREPACK INC.	ANDA	Current
70934-973	Nifedipine	nifedipine	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current