Application 077899

Type: ANDA
Sponsor: PAR PHARM

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
A077899-001	NIFEDIPINE	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13
A077899-002	NIFEDIPINE	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13
A077899-003	NIFEDIPINE	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2012-05-25

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	A077899-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077899-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077899-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2012-05-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077899-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077899-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077899-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2012-05-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077899-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077899-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077899-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2012-05-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077899-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077899-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077899-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2012-05-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077899-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077899-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077899-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2012-05-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077899-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077899-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077899-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2012-05-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077899-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077899-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077899-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2012-05-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077899-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077899-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077899-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2012-05-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077899-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077899-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077899-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2012-05-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077899-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077899-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077899-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2012-05-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077899-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077899-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077899-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2012-05-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077899-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077899-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077899-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2012-05-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077899-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077899-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077899-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2012-05-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077899-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`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	A077899-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077899-002	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077899-003	AB1	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077899-001	AB1	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077899-002	AB1	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077899-003	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077899-001	AB1	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077899-002	AB1	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077899-003	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077899-001	AB1	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077899-002	AB1	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077899-003	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077899-001	AB1	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077899-002	AB1	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077899-003	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077899-001	AB1	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077899-002	AB1	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077899-003	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077899-001	AB1	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077899-002	AB1	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077899-003	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077899-001	AB1	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077899-002	AB1	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077899-003	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 5 of 5 · 88 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nifedipine	NIFEDIPINE	Alembic Pharmaceuticals Limited	1486f187-0ec6-4c70-8991-02c1493912b4	2022-11-28	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Alembic Pharmaceuticals Inc.	63f062f6-5669-434c-8ded-9801d8486dbf	2022-11-23	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Proficient Rx LP	d428aa4d-4cc0-4b1e-b9f6-40ae65a735d6	2022-03-01	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Proficient Rx LP	838d6e8f-37b0-48d3-b701-c4fa32a87b85	2020-02-01	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Proficient Rx LP	4b6418a8-600f-470e-adf1-56207bb25c38	2019-11-01	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Aphena Pharma Solutions - Tennessee, LLC	09a04e5f-d3b0-4ee3-b12d-f74203262179	2019-06-06	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Aphena Pharma Solutions - Tennessee, LLC	95a53fc5-852d-4892-af20-2aaece9399ba	2018-09-13	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Aphena Pharma Solutions - Tennessee, LLC	36b07283-fc0e-4a14-b78f-1d2ab80e7f31	2018-05-07	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 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6544	Nifedipine	Nifedipine	Major Pharmaceuticals	ANDA	Current
0904-6545	Nifedipine	Nifedipine	Major Pharmaceuticals	ANDA	Current
10370-677	Nifedipine	Nifedipine	Par Pharmaceutical, Inc.	ANDA	Current
10370-678	Nifedipine	Nifedipine	Par Pharmaceutical, Inc.	ANDA	Current
10370-679	Nifedipine	Nifedipine	Par Pharmaceutical, Inc.	ANDA	Current
21695-909	Nifedipine	Nifedipine	Rebel Distributors Corp	ANDA	Current
45963-152	Nifedipine	Nifedipine	Actavis Pharma, Inc.	ANDA	Current
45963-152	Nifedipine	Nifedipine	Actavis Pharma, Inc.	ANDA	Current
49884-677	Nifedipine	Nifedipine	Par Pharmaceutical, Inc.	ANDA	Current
49884-678	Nifedipine	Nifedipine	Par Pharmaceutical, Inc.	ANDA	Current
49884-679	Nifedipine	Nifedipine	Par Pharmaceutical, Inc.	ANDA	Current
49999-476	Nifedipine	Nifedipine	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
50090-3034	Nifedipine	Nifedipine	A-S Medication Solutions	ANDA	Current
50090-3034	Nifedipine	Nifedipine	A-S Medication Solutions	ANDA	Current
50090-3035	Nifedipine	Nifedipine	A-S Medication Solutions	ANDA	Current
53808-0387	Nifedipine	NIFEDIPINE	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0389	Nifedipine	NIFEDIPINE	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0898	Nifedipine	Nifedipine	State of Florida DOH Central Pharmacy	ANDA	Current
60687-269	Nifedipine	Nifedipine	American Health Packaging	ANDA	Current