Application 075269

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	30MG	No	No
002	NIFEDIPINE	NIFEDIPINE	TABLET, EXTENDED RELEASE;ORAL	60MG	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
A075269-001	NIFEDIPINE	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2000-12-04
A075269-002	NIFEDIPINE	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2000-12-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075269-001	AB1
A075269-002	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 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	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`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	A075269-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075269-002	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075269-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075269-002	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075269-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075269-002	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075269-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075269-002	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075269-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075269-002	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075269-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075269-002	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075269-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075269-002	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075269-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075269-002	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075269-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075269-002	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075269-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075269-002	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075269-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075269-002	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075269-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075269-002	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075269-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075269-002	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075269-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075269-002	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075269-001	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075269-002	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075269-001	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075269-002	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075269-001	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075269-002	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075269-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075269-002	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075269-001	AB1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075269-002	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075269-001	AB1	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075269-002	AB1	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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nifedipine	NIFEDIPINE	Bryant Ranch Prepack	59724871-b495-4911-a86d-20069ec42edd	2026-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075269 application number: ANDA075269
Nifedipine	NIFEDIPINE	Bryant Ranch Prepack	cb9d013a-2303-4e1d-a539-8ff04d5ec91d	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075269 application number: ANDA075269
Nifedipine	NIFEDIPINE	Bryant Ranch Prepack	0b4e9bbc-4c16-4611-9ea2-903852804227	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075269 application number: ANDA075269
Nifedipine	NIFEDIPINE	Oceanside Pharmaceuticals	fb6d8f32-198e-4ccf-bf25-069c03d624fd	2026-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075269 application number: ANDA075269 ndc (product): 68682-106
Nifedipine	NIFEDIPINE	Northwind Health Company, LLC	d9dec600-4e11-8292-e053-2a95a90a6842	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075269 application number: ANDA075269 ndc (product): 51655-798
Nifedipine	NIFEDIPINE	Oceanside Pharmaceuticals	cb051508-60f3-4b89-9da0-5261024bd7f4	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075269 application number: ANDA075269 ndc (product): 68682-105
Nifedipine	NIFEDIPINE	Aphena Pharma Solutions - Tennessee, LLC	81e6c8e7-e826-4abb-ad58-1dee62091a66	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075269 application number: ANDA075269 ndc (product): 71610-012
Nifedipine	NIFEDIPINE	A-S Medication Solutions	af5a6330-1819-4724-9f08-da45ac9fb478	2023-03-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075269 application number: ANDA075269 ndc (product): 50090-5284
Nifedipine	NIFEDIPINE	Aphena Pharma Solutions - Tennessee, LLC	95a53fc5-852d-4892-af20-2aaece9399ba	2018-09-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075269 application number: ANDA075269 ndc (product): 71610-144

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43353-209	Nifedipine	Nifedipine	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
50090-4234	Nifedipine	Nifedipine	A-S Medication Solutions	ANDA	Current
50090-4234	Nifedipine	Nifedipine	A-S Medication Solutions	ANDA	Current
50090-5284	Nifedipine	Nifedipine	A-S Medication Solutions	ANDA	Current
50090-5284	Nifedipine	Nifedipine	A-S Medication Solutions	ANDA	Current
50090-5284	Nifedipine	Nifedipine	A-S Medication Solutions	ANDA	Current
51655-798	Nifedipine	Nifedipine	Northwind Pharmaceuticals	ANDA	Current
53808-0388	Nifediac CC	Nifedipine	State of Florida DOH Central Pharmacy	ANDA	Current
64725-2057	Nifedipine	Nifedipine	TYA Pharmaceuticals	ANDA	Current
68071-3287	Nifedipine	Nifedipine	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3315	Nifedipine	Nifedipine	NuCare Pharmaceuticals, Inc.	ANDA	Current
68682-105	Nifedipine	Nifedipine	Oceanside Pharmaceuticals	ANDA	Current
68682-105	Nifedipine	Nifedipine	Oceanside Pharmaceuticals	ANDA	Current
68682-105	Nifedipine	Nifedipine	Oceanside Pharmaceuticals	ANDA	Current
68682-106	Nifedipine	Nifedipine	Oceanside Pharmaceuticals	ANDA	Current
68682-106	Nifedipine	Nifedipine	Oceanside Pharmaceuticals	ANDA	Current
68682-106	Nifedipine	Nifedipine	Oceanside Pharmaceuticals	ANDA	Current
71610-012	Nifedipine	Nifedipine	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-012	Nifedipine	Nifedipine	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-012	Nifedipine	Nifedipine	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-144	Nifedipine	Nifedipine	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42968	ORIG	2005-07-22
8589	ORIG	2004-06-10
30827	ORIG	2000-12-04