Application 076070

Type: ANDA
Sponsor: VALEANT PHARMS NORTH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076070-001	NIFEDIPINE	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2002-08-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076070-001	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 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	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`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	A076070-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076070-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076070-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076070-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076070-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076070-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076070-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076070-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076070-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076070-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076070-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076070-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076070-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076070-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076070-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076070-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076070-001	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076070-001	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076070-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076070-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076070-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076070-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076070-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076070-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076070-001	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076070-001	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076070-001	AB1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076070-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076070-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076070-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076070-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076070-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076070-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076070-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076070-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076070-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076070-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076070-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076070-001	AB1	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076070-001	AB1	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 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nifedipine	NIFEDIPINE	Bryant Ranch Prepack	888b3fac-2f2f-42b8-92d1-d37b6ed225a5	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076070 application number: ANDA076070
Nifedipine	NIFEDIPINE	Oceanside Pharmaceuticals	ca5b0178-4e5f-4077-ada5-7058b0a03858	2026-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076070 application number: ANDA076070 ndc (product): 68682-107
Nifedipine	NIFEDIPINE	Aphena Pharma Solutions - Tennessee, LLC	36b07283-fc0e-4a14-b78f-1d2ab80e7f31	2018-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076070 application number: ANDA076070 ndc (product): 71610-055

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
53808-0500	Nifediac CC	Nifedipine	State of Florida DOH Central Pharmacy	ANDA	Current
55700-258	Nifedipine	Nifedipine	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
68071-3382	Nifedipine	Nifedipine	NuCare Pharmaceuticals, Inc.	ANDA	Current
68682-107	Nifedipine	Nifedipine	Oceanside Pharmaceuticals	ANDA	Current
68682-107	Nifedipine	Nifedipine	Oceanside Pharmaceuticals	ANDA	Current
68682-107	Nifedipine	Nifedipine	Oceanside Pharmaceuticals	ANDA	Current
71610-055	Nifedipine	Nifedipine	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43048	ORIG	2005-07-22