Application 202644

Type: ANDA
Sponsor: HERITAGE PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NIFEDIPINE	NIFEDIPINE	CAPSULE;ORAL	10MG	No	No
002	NIFEDIPINE	NIFEDIPINE	CAPSULE;ORAL	20MG	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
A202644-001	NIFEDIPINE	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	RS	2013-04-25
A202644-002	NIFEDIPINE	NIFEDIPINE	20MG	CAPSULE / ORAL	AB		2013-04-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202644-001	AB
A202644-002	AB

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	A202644-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	2013-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202644-002	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	2013-04-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202644-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	2013-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202644-002	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	2013-04-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202644-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	2013-04-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202644-002	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	2013-04-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202644-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	2013-04-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202644-002	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	2013-04-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202644-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	2013-04-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202644-002	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	2013-04-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202644-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	2013-04-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202644-002	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	2013-04-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202644-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	2013-04-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202644-002	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	2013-04-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202644-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	2013-04-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202644-002	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	2013-04-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202644-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	2013-04-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202644-002	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	2013-04-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202644-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	2013-04-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202644-002	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	2013-04-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202644-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	2013-04-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202644-002	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	2013-04-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202644-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	2013-04-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202644-002	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	2013-04-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202644-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	2013-04-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202644-002	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	2013-04-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202644-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	2013-04-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202644-002	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	2013-04-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202644-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	2013-04-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202644-002	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	2013-04-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202644-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	2013-04-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202644-002	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	2013-04-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202644-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	2013-04-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202644-002	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	2013-04-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202644-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	2013-04-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202644-002	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	2013-04-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202644-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	2013-04-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202644-002	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	2013-04-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202644-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	2013-04-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202644-002	NIFEDIPINE	20MG	CAPSULE / ORAL	AB	2013-04-25	`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	A202644-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202644-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202644-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202644-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202644-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202644-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202644-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202644-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202644-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202644-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202644-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202644-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202644-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202644-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202644-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202644-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202644-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202644-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202644-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202644-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202644-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202644-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202644-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202644-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202644-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202644-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202644-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202644-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202644-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202644-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202644-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202644-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202644-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202644-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202644-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202644-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202644-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202644-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202644-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202644-002	AB	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nifedipine	NIFEDIPINE	Major Pharmaceuticals	acb493a3-b8f2-41a9-8ab2-550d97c4592a	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202644 application number: ANDA202644 ndc (product): 0904-7229
Nifedipine	NIFEDIPINE	REMEDYREPACK INC.	bddfd658-ac61-4ba2-a3fa-07acc35d368a	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202644 application number: ANDA202644
Nifedipine	NIFEDIPINE	Cardinal Health 107, LLC	472621b6-c2b7-4582-9ceb-7cead55ff247	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202644 application number: ANDA202644
Nifedipine	NIFEDIPINE	Chartwell RX, LLC	5014847e-389d-48c1-8350-b9b24ca8d2a4	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202644 application number: ANDA202644
Nifedipine	NIFEDIPINE	PD-Rx Pharmaceuticals, Inc.	51cdb22b-035f-47d7-8048-38006e2589f2	2025-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202644 application number: ANDA202644 ndc (product): 72789-219
Nifedipine	NIFEDIPINE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	b8b8cfee-ea71-44c2-81af-675efecfdf15	2023-08-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202644 application number: ANDA202644 ndc (product): 23155-194 ndc (product): 23155-195

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-7229	Nifedipine	Nifedipine	Major Pharmaceuticals	ANDA	Current
23155-194	Nifedipine	Nifedipine	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-194	Nifedipine	Nifedipine	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-194	Nifedipine	Nifedipine	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-195	Nifedipine	Nifedipine	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-195	Nifedipine	Nifedipine	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-195	Nifedipine	Nifedipine	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
72789-219	Nifedipine	Nifedipine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-219	Nifedipine	Nifedipine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-219	Nifedipine	Nifedipine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current