Application 091001

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NISOLDIPINE	NISOLDIPINE	TABLET, EXTENDED RELEASE;ORAL	8.5MG	No	No
002	NISOLDIPINE	NISOLDIPINE	TABLET, EXTENDED RELEASE;ORAL	17MG	No	No
003	NISOLDIPINE	NISOLDIPINE	TABLET, EXTENDED RELEASE;ORAL	25.5MG	No	No
004	NISOLDIPINE	NISOLDIPINE	TABLET, EXTENDED RELEASE;ORAL	34MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A091001-001	NISOLDIPINE	NISOLDIPINE	8.5MG	TABLET, EXTENDED RELEASE / ORAL	2011-01-26
A091001-002	NISOLDIPINE	NISOLDIPINE	17MG	TABLET, EXTENDED RELEASE / ORAL	2011-01-26
A091001-003	NISOLDIPINE	NISOLDIPINE	25.5MG	TABLET, EXTENDED RELEASE / ORAL	2011-01-26
A091001-004	NISOLDIPINE	NISOLDIPINE	34MG	TABLET, EXTENDED RELEASE / ORAL	2011-01-26

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 5 · 172 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
2026-09-14 22:38:34	2026-08	A091001-001	NISOLDIPINE	8.5MG	TABLET, EXTENDED RELEASE / ORAL		2011-01-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091001-002	NISOLDIPINE	17MG	TABLET, EXTENDED RELEASE / ORAL		2011-01-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091001-003	NISOLDIPINE	25.5MG	TABLET, EXTENDED RELEASE / ORAL		2011-01-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091001-004	NISOLDIPINE	34MG	TABLET, EXTENDED RELEASE / ORAL		2011-01-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091001-001	NISOLDIPINE	8.5MG	TABLET, EXTENDED RELEASE / ORAL		2011-01-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091001-002	NISOLDIPINE	17MG	TABLET, EXTENDED RELEASE / ORAL		2011-01-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091001-003	NISOLDIPINE	25.5MG	TABLET, EXTENDED RELEASE / ORAL		2011-01-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091001-004	NISOLDIPINE	34MG	TABLET, EXTENDED RELEASE / ORAL		2011-01-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091001-001	NISOLDIPINE	8.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091001-002	NISOLDIPINE	17MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091001-003	NISOLDIPINE	25.5MG	TABLET, EXTENDED RELEASE / ORAL		2011-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091001-004	NISOLDIPINE	34MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091001-001	NISOLDIPINE	8.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091001-002	NISOLDIPINE	17MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091001-003	NISOLDIPINE	25.5MG	TABLET, EXTENDED RELEASE / ORAL		2011-01-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091001-004	NISOLDIPINE	34MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091001-001	NISOLDIPINE	8.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091001-002	NISOLDIPINE	17MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091001-003	NISOLDIPINE	25.5MG	TABLET, EXTENDED RELEASE / ORAL		2011-01-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091001-004	NISOLDIPINE	34MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091001-001	NISOLDIPINE	8.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091001-002	NISOLDIPINE	17MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091001-003	NISOLDIPINE	25.5MG	TABLET, EXTENDED RELEASE / ORAL		2011-01-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091001-004	NISOLDIPINE	34MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091001-001	NISOLDIPINE	8.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091001-002	NISOLDIPINE	17MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091001-003	NISOLDIPINE	25.5MG	TABLET, EXTENDED RELEASE / ORAL		2011-01-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091001-004	NISOLDIPINE	34MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091001-001	NISOLDIPINE	8.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091001-002	NISOLDIPINE	17MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091001-003	NISOLDIPINE	25.5MG	TABLET, EXTENDED RELEASE / ORAL		2011-01-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091001-004	NISOLDIPINE	34MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091001-001	NISOLDIPINE	8.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091001-002	NISOLDIPINE	17MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091001-003	NISOLDIPINE	25.5MG	TABLET, EXTENDED RELEASE / ORAL		2011-01-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091001-004	NISOLDIPINE	34MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091001-001	NISOLDIPINE	8.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091001-002	NISOLDIPINE	17MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091001-003	NISOLDIPINE	25.5MG	TABLET, EXTENDED RELEASE / ORAL		2011-01-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091001-004	NISOLDIPINE	34MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 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	A091001-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091001-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091001-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091001-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091001-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091001-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091001-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091001-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091001-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091001-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091001-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091001-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091001-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091001-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091001-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091001-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091001-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091001-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091001-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091001-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091001-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091001-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091001-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091001-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091001-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091001-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091001-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091001-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091001-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091001-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091001-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091001-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091001-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091001-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091001-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091001-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091001-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091001-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091001-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091001-001	AB	1	`8072bd15b7f6…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
nisoldipine	NISOLDIPINE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	a52b773a-44f9-442f-a4be-39f79a558bd2	2026-06-08	Warnings, Adverse reactions	Name fallback brand name: nisoldipine generic name: NISOLDIPINE
Sular	NISOLDIPINE	Covis Pharma US, Inc	589157fa-d129-4de3-be3d-e0e1c22c5873	2026-03-12	Warnings, Adverse reactions	Name fallback generic name: NISOLDIPINE
Nisoldipine	NISOLDIPINE	Prasco Laboratories	8a5fb6a2-9fae-4872-8c5c-0f1ba03a57cb	2021-10-01	Warnings, Adverse reactions	Name fallback brand name: Nisoldipine generic name: NISOLDIPINE

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-2096	Nisoldipine	nisoldipine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2096	Nisoldipine	nisoldipine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2096	Nisoldipine	nisoldipine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2097	Nisoldipine	nisoldipine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2097	Nisoldipine	nisoldipine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2097	Nisoldipine	nisoldipine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2098	Nisoldipine	nisoldipine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2098	Nisoldipine	nisoldipine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2098	Nisoldipine	nisoldipine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2099	Nisoldipine	nisoldipine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2099	Nisoldipine	nisoldipine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2099	Nisoldipine	nisoldipine	Mylan Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9309	ORIG	2011-02-03