Application 074045

Type: ANDA
Sponsor: LEADING PHARMA LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NIFEDIPINE	NIFEDIPINE	CAPSULE;ORAL	20MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074045-001	NIFEDIPINE	NIFEDIPINE	20MG	CAPSULE / ORAL	AB		1992-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074045-001	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 2 · 42 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	A074045-001	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	1992-04-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074045-001	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	1992-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074045-001	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	1992-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074045-001	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	1992-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074045-001	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	1992-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074045-001	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	1992-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074045-001	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	1992-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074045-001	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	1992-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074045-001	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	1992-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074045-001	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	1992-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074045-001	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	1992-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074045-001	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	1992-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074045-001	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	1992-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074045-001	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	1992-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074045-001	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	1992-04-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074045-001	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	1992-04-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074045-001	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	1992-04-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074045-001	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	1992-04-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074045-001	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	1992-04-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074045-001	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	1992-04-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074045-001	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	1992-04-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074045-001	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	1992-04-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074045-001	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	1992-04-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074045-001	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	1992-04-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074045-001	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	1992-04-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074045-001	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	1992-04-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074045-001	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	1992-04-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074045-001	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	1992-04-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074045-001	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	1992-04-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074045-001	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	1992-04-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074045-001	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	1992-04-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074045-001	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	1992-04-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074045-001	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	1992-04-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074045-001	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	1992-04-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074045-001	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	1992-04-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074045-001	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	1992-04-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074045-001	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	1992-04-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074045-001	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	1992-04-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074045-001	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	1992-04-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074045-001	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	1992-04-30	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A074045-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074045-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074045-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074045-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074045-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074045-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074045-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074045-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074045-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074045-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074045-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074045-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074045-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074045-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074045-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074045-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074045-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074045-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074045-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074045-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074045-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074045-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074045-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074045-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074045-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074045-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074045-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074045-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074045-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074045-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074045-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074045-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074045-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074045-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074045-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074045-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074045-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074045-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074045-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074045-001	AB	1	`e64feba35796…`

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 5 · 89 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nifedipine	NIFEDIPINE	Preferred Pharmaceuticals Inc.	cda16a27-f029-40a6-a0e8-2bed0de71169	2026-08-04	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Preferred Pharmaceuticals, Inc.	4ee466dc-5a4e-4c77-8e94-8b510cafd61b	2026-08-04	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Major Pharmaceuticals	acb493a3-b8f2-41a9-8ab2-550d97c4592a	2026-06-30	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	St. Mary's Medical Park Pharmacy	1add684f-d082-72cc-e063-6394a90a1214	2026-06-29	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	St. Mary's Medical Park Pharmacy	1ab8945b-bea5-9827-e063-6294a90af334	2026-06-17	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Golden State Medical Supply, Inc.	d9a501be-8523-3924-e053-2995a90a8569	2026-06-16	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Cardinal Health 107, LLC	c98ecf77-ae9a-438b-9bad-ffbed25d95bc	2026-06-11	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
nifedipine	NIFEDIPINE	Bryant Ranch Prepack	d7475c68-6310-4b9a-81c1-9209a9ade75f	2026-06-04	Warnings, Adverse reactions	Name fallback brand name: nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Bryant Ranch Prepack	e1cd5011-b80e-4b1b-8729-56260b8b3c26	2026-05-15	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Coupler LLC	518d39af-0be1-acbc-e063-6294a90a4ada	2026-05-11	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Major Pharmaceuticals	41aa6fbd-96c1-40f7-92d4-cfdd2d5325e9	2026-04-30	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	REMEDYREPACK INC.	bddfd658-ac61-4ba2-a3fa-07acc35d368a	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Bryant Ranch Prepack	59724871-b495-4911-a86d-20069ec42edd	2026-04-22	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Ingenus Pharmaceuticals, LLC	4d02eba2-e964-4fa7-aaae-25949b5f0316	2026-04-15	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Cardinal Health 107, LLC	472621b6-c2b7-4582-9ceb-7cead55ff247	2026-04-09	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Ingenus Pharmaceuticals, LLC	4d3e11d2-d320-45d3-96c8-48322202b504	2026-03-30	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Bryant Ranch Prepack	cb9d013a-2303-4e1d-a539-8ff04d5ec91d	2026-03-25	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Bryant Ranch Prepack	0b4e9bbc-4c16-4611-9ea2-903852804227	2026-03-19	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Bryant Ranch Prepack	888b3fac-2f2f-42b8-92d1-d37b6ed225a5	2026-03-19	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Major Pharmaceuticals	b885b6b5-71c6-4799-8b23-5ee8c17938a0	2026-03-03	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69315-212	NIFEDIPINE	NIFEDIPINE	Leading Pharma, LLC	ANDA	Current
69315-212	NIFEDIPINE	NIFEDIPINE	Leading Pharma, LLC	ANDA	Current
69315-212	NIFEDIPINE	NIFEDIPINE	Leading Pharma, LLC	ANDA	Current
69315-212	NIFEDIPINE	NIFEDIPINE	Leading Pharma, LLC	ANDA	Current