Application 072579

Type: ANDA
Sponsor: ACTAVIS ELIZABETH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NIFEDIPINE	NIFEDIPINE	CAPSULE;ORAL	10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A072579-001	NIFEDIPINE	NIFEDIPINE	10MG	CAPSULE / ORAL	AB		1991-01-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A072579-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A072579-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	1991-01-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072579-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	1991-01-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072579-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	1991-01-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072579-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	1991-01-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072579-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	1991-01-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072579-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	1991-01-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072579-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	1991-01-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072579-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	1991-01-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072579-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	1991-01-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072579-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	1991-01-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072579-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	1991-01-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072579-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	1991-01-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072579-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	1991-01-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072579-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	1991-01-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072579-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	1991-01-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072579-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	1991-01-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072579-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	1991-01-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072579-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	1991-01-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072579-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	1991-01-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072579-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	1991-01-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072579-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	1991-01-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072579-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	1991-01-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072579-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	1991-01-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072579-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	1991-01-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072579-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	1991-01-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072579-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	1991-01-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072579-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	1991-01-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072579-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	1991-01-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072579-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	1991-01-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072579-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	1991-01-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072579-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	1991-01-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072579-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	1991-01-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072579-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	1991-01-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072579-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	1991-01-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072579-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	1991-01-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072579-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	1991-01-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072579-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	1991-01-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072579-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	1991-01-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072579-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	1991-01-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072579-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	1991-01-08	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A072579-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072579-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072579-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072579-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072579-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072579-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072579-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072579-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072579-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072579-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072579-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072579-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072579-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072579-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072579-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072579-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072579-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072579-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072579-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072579-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072579-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072579-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072579-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072579-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072579-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072579-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072579-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072579-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072579-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072579-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072579-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072579-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072579-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072579-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072579-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072579-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072579-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072579-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072579-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072579-001	AB	1	`cb3db0bc1861…`

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 3 of 5 · 89 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nifedipine	NIFEDIPINE	Chartwell RX, LLC	5014847e-389d-48c1-8350-b9b24ca8d2a4	2025-12-17	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	A-S Medication Solutions	9f64a8d7-dfbf-4a81-81bd-b09cfe7cbd44	2025-12-16	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Procardia XL	NIFEDIPINE	Pfizer Laboratories Div Pfizer Inc	8ebcb33c-f43b-4b36-9f94-9774b2a59e06	2025-12-16	Warnings, Adverse reactions	Name fallback generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Redpharm Drug	32526983-f53a-fa68-e063-6394a90aa13f	2025-12-13	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Golden State Medical Supply, Inc.	a84be46e-bb0c-d59f-e053-2a95a90aabde	2025-12-11	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Redpharm Drug	3b0ae3ed-77ee-d0df-e063-6294a90a7d17	2025-12-02	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Oceanside Pharmaceuticals	cb051508-60f3-4b89-9da0-5261024bd7f4	2025-12-01	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	PD-Rx Pharmaceuticals, Inc.	86c1bdae-c749-4ec3-90f6-7ebe8e76c461	2025-10-20	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	PD-Rx Pharmaceuticals, Inc.	51cdb22b-035f-47d7-8048-38006e2589f2	2025-10-08	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Bryant Ranch Prepack	5432254e-ce27-4a67-9eba-e06e092cb93d	2025-09-19	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Bryant Ranch Prepack	7dc5eec6-f32a-45e6-af24-830738cae471	2025-09-19	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Bryant Ranch Prepack	1bd05e73-5104-4ef7-a705-22e2db140354	2025-09-19	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Preferred Pharmaceuticals Inc.	cda16a27-f029-40a6-a0e8-2bed0de71169	2025-08-19	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Preferred Pharmaceuticals, Inc.	4ee466dc-5a4e-4c77-8e94-8b510cafd61b	2025-08-19	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	REMEDYREPACK INC.	832fc274-605a-4b04-b327-dbf361131621	2025-07-24	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Ascend Laboratories, LLC	f661c1d9-f0f6-4595-82dd-f656bff974f1	2025-06-16	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Cardinal Health 107, LLC	593d8ca3-c303-4512-96a6-d4860e02cd83	2025-06-09	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	American Health Packaging	b11026f8-dea0-49ac-8725-0ef7dc27923f	2025-05-16	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Bryant Ranch Prepack	325acf27-4b2e-40e8-8344-bb6cc9959910	2025-03-27	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	PD-Rx Pharmaceuticals, Inc.	75003769-7800-4bc7-b709-35b4caec2c2f	2025-03-17	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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0228-2497	Nifedipine	Nifedipine	Actavis Pharma, Inc.	ANDA	Current
0228-2497	Nifedipine	Nifedipine	Actavis Pharma, Inc.	ANDA	Current
50268-600	Nifedipine	Nifedipine	AvPAK	ANDA	Current
55154-4994	Nifedipine	Nifedipine	Cardinal Health	ANDA	Current
68084-022	Nifedipine	Nifedipine	American Health Packaging	ANDA	Current