Application 019684

Type: NDA
Sponsor: PFIZER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROCARDIA XL	NIFEDIPINE	TABLET, EXTENDED RELEASE;ORAL	30MG	Yes	No
002	PROCARDIA XL	NIFEDIPINE	TABLET, EXTENDED RELEASE;ORAL	60MG	Yes	No
003	PROCARDIA XL	NIFEDIPINE	TABLET, EXTENDED RELEASE;ORAL	90MG	Yes	Yes

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	TE codes	RLD / RS	Approval date
N019684-001	PROCARDIA XL	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1989-09-06
N019684-002	PROCARDIA XL	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1989-09-06
N019684-003	PROCARDIA XL	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL		RLD	1989-09-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N019684-001	AB2
N019684-002	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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019684-001	PROCARDIA XL	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1989-09-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019684-002	PROCARDIA XL	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1989-09-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019684-003	PROCARDIA XL	90MG	TABLET, EXTENDED RELEASE / ORAL		RLD	1989-09-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019684-001	PROCARDIA XL	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1989-09-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019684-002	PROCARDIA XL	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1989-09-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019684-003	PROCARDIA XL	90MG	TABLET, EXTENDED RELEASE / ORAL		RLD	1989-09-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019684-001	PROCARDIA XL	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1989-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019684-002	PROCARDIA XL	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1989-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019684-003	PROCARDIA XL	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD, RS	1989-09-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019684-001	PROCARDIA XL	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1989-09-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019684-002	PROCARDIA XL	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1989-09-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019684-003	PROCARDIA XL	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD, RS	1989-09-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019684-001	PROCARDIA XL	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1989-09-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019684-002	PROCARDIA XL	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1989-09-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019684-003	PROCARDIA XL	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD, RS	1989-09-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019684-001	PROCARDIA XL	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1989-09-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019684-002	PROCARDIA XL	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1989-09-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019684-003	PROCARDIA XL	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD, RS	1989-09-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019684-001	PROCARDIA XL	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1989-09-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019684-002	PROCARDIA XL	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1989-09-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019684-003	PROCARDIA XL	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD, RS	1989-09-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019684-001	PROCARDIA XL	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1989-09-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019684-002	PROCARDIA XL	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1989-09-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019684-003	PROCARDIA XL	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD, RS	1989-09-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019684-001	PROCARDIA XL	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1989-09-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019684-002	PROCARDIA XL	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1989-09-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019684-003	PROCARDIA XL	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD, RS	1989-09-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019684-001	PROCARDIA XL	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1989-09-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019684-002	PROCARDIA XL	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1989-09-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019684-003	PROCARDIA XL	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD, RS	1989-09-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019684-001	PROCARDIA XL	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1989-09-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019684-002	PROCARDIA XL	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1989-09-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019684-003	PROCARDIA XL	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD, RS	1989-09-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019684-001	PROCARDIA XL	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1989-09-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019684-002	PROCARDIA XL	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1989-09-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019684-003	PROCARDIA XL	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD, RS	1989-09-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019684-001	PROCARDIA XL	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1989-09-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019684-002	PROCARDIA XL	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1989-09-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019684-003	PROCARDIA XL	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD, RS	1989-09-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019684-001	PROCARDIA XL	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1989-09-06	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 4 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-09-29 23:25 UTC	2022-09	N019684-003	AB2	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019684-001	AB2	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019684-002	AB2	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019684-003	AB2	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N019684-001	AB2	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N019684-002	AB2	1	`a50c72e98297…`

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 5 · 88 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nifedipine	NIFEDIPINE	Preferred Pharmaceuticals Inc.	cda16a27-f029-40a6-a0e8-2bed0de71169	2026-08-04	Warnings, Adverse reactions	Name fallback generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Preferred Pharmaceuticals, Inc.	4ee466dc-5a4e-4c77-8e94-8b510cafd61b	2026-08-04	Warnings, Adverse reactions	Name fallback generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Major Pharmaceuticals	acb493a3-b8f2-41a9-8ab2-550d97c4592a	2026-06-30	Warnings, Adverse reactions	Name fallback generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	St. Mary's Medical Park Pharmacy	1add684f-d082-72cc-e063-6394a90a1214	2026-06-29	Warnings, Adverse reactions	Name fallback generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	St. Mary's Medical Park Pharmacy	1ab8945b-bea5-9827-e063-6294a90af334	2026-06-17	Warnings, Adverse reactions	Name fallback generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Golden State Medical Supply, Inc.	d9a501be-8523-3924-e053-2995a90a8569	2026-06-16	Warnings, Adverse reactions	Name fallback generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Cardinal Health 107, LLC	c98ecf77-ae9a-438b-9bad-ffbed25d95bc	2026-06-11	Warnings, Adverse reactions	Name fallback generic name: NIFEDIPINE
nifedipine	NIFEDIPINE	Bryant Ranch Prepack	d7475c68-6310-4b9a-81c1-9209a9ade75f	2026-06-04	Warnings, Adverse reactions	Name fallback generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Bryant Ranch Prepack	e1cd5011-b80e-4b1b-8729-56260b8b3c26	2026-05-15	Warnings, Adverse reactions	Name fallback generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Coupler LLC	518d39af-0be1-acbc-e063-6294a90a4ada	2026-05-11	Warnings, Adverse reactions	Name fallback generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Major Pharmaceuticals	41aa6fbd-96c1-40f7-92d4-cfdd2d5325e9	2026-04-30	Warnings, Adverse reactions	Name fallback generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	REMEDYREPACK INC.	bddfd658-ac61-4ba2-a3fa-07acc35d368a	2026-04-24	Warnings, Adverse reactions	Name fallback generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Bryant Ranch Prepack	59724871-b495-4911-a86d-20069ec42edd	2026-04-22	Warnings, Adverse reactions	Name fallback generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Ingenus Pharmaceuticals, LLC	4d02eba2-e964-4fa7-aaae-25949b5f0316	2026-04-15	Warnings, Adverse reactions	Name fallback generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Cardinal Health 107, LLC	472621b6-c2b7-4582-9ceb-7cead55ff247	2026-04-09	Warnings, Adverse reactions	Name fallback generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Ingenus Pharmaceuticals, LLC	4d3e11d2-d320-45d3-96c8-48322202b504	2026-03-30	Warnings, Adverse reactions	Name fallback generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Bryant Ranch Prepack	cb9d013a-2303-4e1d-a539-8ff04d5ec91d	2026-03-25	Warnings, Adverse reactions	Name fallback generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Bryant Ranch Prepack	0b4e9bbc-4c16-4611-9ea2-903852804227	2026-03-19	Warnings, Adverse reactions	Name fallback generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Bryant Ranch Prepack	888b3fac-2f2f-42b8-92d1-d37b6ed225a5	2026-03-19	Warnings, Adverse reactions	Name fallback generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Major Pharmaceuticals	b885b6b5-71c6-4799-8b23-5ee8c17938a0	2026-03-03	Warnings, Adverse reactions	Name fallback 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
0069-2650	Procardia	nifedipine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2650	Procardia	nifedipine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2650	Procardia	nifedipine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2660	Procardia	nifedipine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2660	Procardia	nifedipine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2660	Procardia	nifedipine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2670	Procardia	nifedipine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2670	Procardia	nifedipine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2670	Procardia	nifedipine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
53808-0496	nifedipine	NIFEDIPINE	State of Florida DOH Central Pharmacy	NDA	Current
59762-6690	nifedipine	nifedipine	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-6690	nifedipine	nifedipine	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-6691	nifedipine	nifedipine	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-6691	nifedipine	nifedipine	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-6692	nifedipine	nifedipine	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-6692	nifedipine	nifedipine	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
67046-515	nifedipine	nifedipine	Contract Pharmacy Services-PA	NDA	Current
70518-0600	Procardia	nifedipine	REMEDYREPACK INC.	NDA	Current
70518-0600	Procardia	nifedipine	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69771	SUPPL	2021-12-27
69287	SUPPL	2021-11-10
11636	SUPPL	2015-01-14
19101	SUPPL	2015-01-12
33871	SUPPL	2014-05-12
19100	SUPPL	2014-05-08
33870	SUPPL	2013-07-30
1511	SUPPL	2013-07-29
19099	SUPPL	2011-10-03
33869	SUPPL	2011-09-30
1510	SUPPL	2010-10-07
33868	SUPPL	2010-10-04
20288	SUPPL	1997-01-08