Application 018869

Type: NDA
Sponsor: BAYER PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NIMOTOP	NIMODIPINE	CAPSULE;ORAL	30MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018869-001	NIMOTOP	NIMODIPINE	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1988-12-28

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018869-001	NIMOTOP	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1988-12-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018869-001	NIMOTOP	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1988-12-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018869-001	NIMOTOP	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1988-12-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018869-001	NIMOTOP	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1988-12-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018869-001	NIMOTOP	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1988-12-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018869-001	NIMOTOP	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1988-12-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018869-001	NIMOTOP	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1988-12-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018869-001	NIMOTOP	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1988-12-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018869-001	NIMOTOP	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1988-12-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018869-001	NIMOTOP	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1988-12-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018869-001	NIMOTOP	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1988-12-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018869-001	NIMOTOP	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1988-12-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018869-001	NIMOTOP	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1988-12-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018869-001	NIMOTOP	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1988-12-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018869-001	NIMOTOP	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1988-12-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018869-001	NIMOTOP	30MG	CAPSULE / ORAL	RLD	1988-12-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018869-001	NIMOTOP	30MG	CAPSULE / ORAL	RLD	1988-12-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018869-001	NIMOTOP	30MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD	1988-12-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018869-001	NIMOTOP	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1988-12-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018869-001	NIMOTOP	30MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD	1988-12-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018869-001	NIMOTOP	30MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD	1988-12-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018869-001	NIMOTOP	30MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD	1988-12-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018869-001	NIMOTOP	30MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD	1988-12-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018869-001	NIMOTOP	30MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD	1988-12-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018869-001	NIMOTOP	30MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD	1988-12-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018869-001	NIMOTOP	30MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD	1988-12-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018869-001	NIMOTOP	30MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD	1988-12-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018869-001	NIMOTOP	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1988-12-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018869-001	NIMOTOP	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1988-12-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018869-001	NIMOTOP	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1988-12-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018869-001	NIMOTOP	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1988-12-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018869-001	NIMOTOP	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1988-12-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018869-001	NIMOTOP	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1988-12-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018869-001	NIMOTOP	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1988-12-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018869-001	NIMOTOP	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1988-12-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018869-001	NIMOTOP	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1988-12-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018869-001	NIMOTOP	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1988-12-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018869-001	NIMOTOP	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1988-12-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018869-001	NIMOTOP	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1988-12-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018869-001	NIMOTOP	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1988-12-28	`cb3db0bc1861…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nimodipine	NIMODIPINE	BIONPHARMA INC.	e65d5108-22a2-4d87-a78d-15606f3cc9e2	2025-12-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NIMODIPINE
Nymalize	NIMODIPINE	Azurity Pharmaceuticals, Inc.	e660fa26-b5c4-4d6d-8887-9e22b6666a10	2024-08-30	Warnings, Adverse reactions	Name fallback generic name: NIMODIPINE
nimodipine	NIMODIPINE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	a323ebd8-ef1b-439b-93d1-ba73a5b0127d	2024-08-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NIMODIPINE
Nimodipine	NIMODIPINE	Camber Pharmaceuticals, Inc.	f829de8b-fabd-4aec-ac8d-c9aaef7be55b	2024-07-20	Warnings, Adverse reactions	Name fallback generic name: NIMODIPINE

Documents#

Document, Submission type, Date table
Document	Submission type	Date
16074	SUPPL	2006-01-30
33628	SUPPL	2006-01-27
33627	SUPPL	2000-08-22
1108	SUPPL	2000-08-22