Application 201071

Type: ANDA
Sponsor: MYLAN

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 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	Approval date
A201071-001	NIFEDIPINE	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03
A201071-002	NIFEDIPINE	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03
A201071-003	NIFEDIPINE	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A201071-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201071-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201071-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201071-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201071-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201071-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201071-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201071-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201071-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201071-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201071-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201071-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201071-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201071-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201071-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201071-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201071-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201071-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201071-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201071-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201071-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201071-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201071-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201071-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201071-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201071-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201071-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201071-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201071-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201071-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201071-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201071-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201071-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201071-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201071-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201071-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201071-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201071-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201071-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201071-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A201071-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201071-002	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201071-003	AB1	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201071-001	AB1	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201071-002	AB1	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201071-003	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201071-001	AB1	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A201071-002	AB1	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A201071-003	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201071-001	AB1	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A201071-002	AB1	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A201071-003	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201071-001	AB1	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A201071-002	AB1	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A201071-003	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201071-001	AB1	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A201071-002	AB1	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A201071-003	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201071-001	AB1	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201071-002	AB1	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201071-003	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201071-001	AB1	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201071-002	AB1	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201071-003	AB1	1	`ea99ee380514…`

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 · 88 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nifedipine	NIFEDIPINE	Northwind Health Company, LLC	e3b04484-f330-9523-e053-2995a90a0e45	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Chartwell RX, LLC	0a8e3090-7733-4914-bacb-01bbdc8deb30	2025-12-17	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
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
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	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
Nifedipine	NIFEDIPINE	NuCare Pharmaceuticals,Inc.	d5df10bc-16ed-7a97-e053-2a95a90ab15e	2024-12-24	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE

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 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-0353	Nifedipine	nifedipine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0360	Nifedipine	nifedipine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0390	Nifedipine	nifedipine	Mylan Pharmaceuticals Inc.	ANDA	Current
43353-750	Nifedipine	nifedipine	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-750	Nifedipine	nifedipine	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-836	Nifedipine	nifedipine	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-836	Nifedipine	nifedipine	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-929	Nifedipine	nifedipine	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
50090-2917	Nifedipine	nifedipine	A-S Medication Solutions	ANDA	Current
70518-0747	Nifedipine	nifedipine	REMEDYREPACK INC.	ANDA	Current
70518-0747	Nifedipine	nifedipine	REMEDYREPACK INC.	ANDA	Current