Application 075289

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	60MG	No	No
002	NIFEDIPINE	NIFEDIPINE	TABLET, EXTENDED RELEASE;ORAL	30MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075289-001	NIFEDIPINE	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2000-09-27
A075289-002	NIFEDIPINE	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2001-02-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A075289-001	AB2
A075289-002	AB2

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 3 · 82 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	A075289-001	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2000-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075289-002	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2001-02-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075289-001	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2000-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075289-002	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2001-02-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075289-001	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2000-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075289-002	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2001-02-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075289-001	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2000-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075289-002	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2001-02-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075289-001	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2000-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075289-002	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2001-02-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075289-001	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2000-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075289-002	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2001-02-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075289-001	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2000-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075289-002	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2001-02-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075289-001	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2000-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075289-002	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2001-02-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075289-001	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2000-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075289-002	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2001-02-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075289-001	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2000-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075289-002	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2001-02-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075289-001	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2000-09-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075289-002	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2001-02-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075289-001	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2000-09-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075289-002	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2001-02-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075289-001	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2000-09-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075289-002	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2001-02-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075289-001	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2000-09-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075289-002	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2001-02-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075289-001	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2000-09-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075289-002	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2001-02-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075289-001	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2000-09-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075289-002	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2001-02-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075289-001	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2000-09-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075289-002	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2001-02-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075289-001	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2000-09-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075289-002	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2001-02-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075289-001	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2000-09-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075289-002	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2001-02-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075289-001	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2000-09-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075289-002	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2001-02-06	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A075289-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075289-002	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075289-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075289-002	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075289-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075289-002	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075289-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075289-002	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075289-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075289-002	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075289-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075289-002	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075289-001	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075289-002	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075289-001	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075289-002	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075289-001	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075289-002	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075289-001	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075289-002	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075289-001	AB2	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075289-002	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075289-001	AB2	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075289-002	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075289-001	AB2	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075289-002	AB2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075289-001	AB2	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075289-002	AB2	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075289-001	AB2	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075289-002	AB2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075289-001	AB2	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075289-002	AB2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075289-001	AB2	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075289-002	AB2	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075289-001	AB2	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075289-002	AB2	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075289-001	AB2	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075289-002	AB2	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075289-001	AB2	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075289-002	AB2	1	`782e0a99824c…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
nifedipine	NIFEDIPINE	Bryant Ranch Prepack	d7475c68-6310-4b9a-81c1-9209a9ade75f	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075289 application number: ANDA075289 ndc (product): 71335-0744
nifedipine	NIFEDIPINE	Oceanside Pharmaceuticals	c7874606-c71e-424c-b881-38697988e0d0	2026-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075289 application number: ANDA075289 ndc (product): 68682-109 ndc (product): 68682-108

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-2939	Nifedipine	nifedipine	A-S Medication Solutions	ANDA	Current
53217-010	NifedicalXL	nifedipine	Aidarex Pharmaceuticals LLC	ANDA	Current
53808-0851	Nifedical	nifedipine	State of Florida DOH Central Pharmacy	ANDA	Current
55154-4837	Nifedical	nifedipine	Cardinal Health	ANDA	Current
63629-1559	Nifedical	nifedipine	Bryant Ranch Prepack	ANDA	Current
68071-3025	Nifedipine	nifedipine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4281	nifedipine	nifedipine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4281	nifedipine	nifedipine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4281	nifedipine	nifedipine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68682-108	nifedipine	nifedipine	Oceanside Pharmaceuticals	ANDA	Current
68682-108	nifedipine	nifedipine	Oceanside Pharmaceuticals	ANDA	Current
68682-108	nifedipine	nifedipine	Oceanside Pharmaceuticals	ANDA	Current
68682-109	nifedipine	nifedipine	Oceanside Pharmaceuticals	ANDA	Current
68682-109	nifedipine	nifedipine	Oceanside Pharmaceuticals	ANDA	Current
68682-109	nifedipine	nifedipine	Oceanside Pharmaceuticals	ANDA	Current
70518-1740	nifedipine	nifedipine	REMEDYREPACK INC.	ANDA	Current
70518-1740	nifedipine	nifedipine	REMEDYREPACK INC.	ANDA	Current
70934-963	nifedipine	nifedipine	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71335-0744	nifedipine	nifedipine	Bryant Ranch Prepack	ANDA	Current
71335-0744	nifedipine	nifedipine	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22455	ORIG	2005-07-22
8601	SUPPL	2001-02-06