Application 201832

Type: ANDA
Sponsor: SOFGEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NIMODIPINE	NIMODIPINE	CAPSULE;ORAL	30MG	No	No

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

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
A201832-001	NIMODIPINE	NIMODIPINE	30MG	CAPSULE / ORAL			2015-07-24

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 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A201832-001	NIMODIPINE	30MG	CAPSULE / ORAL	2015-07-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201832-001	NIMODIPINE	30MG	CAPSULE / ORAL	2015-07-24	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A201832-001	NIMODIPINE	30MG	CAPSULE / ORAL	2015-07-24	`a50c72e98297…`

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	A201832-001	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201832-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201832-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201832-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201832-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201832-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201832-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201832-001	AB	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 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 brand name: Nimodipine 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 brand name: nimodipine generic name: NIMODIPINE
Nimodipine	NIMODIPINE	Camber Pharmaceuticals, Inc.	f829de8b-fabd-4aec-ac8d-c9aaef7be55b	2024-07-20	Warnings, Adverse reactions	Name fallback brand name: Nimodipine generic name: NIMODIPINE

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62559-210	Nimodipine	Nimodipine	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-210	Nimodipine	Nimodipine	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-210	Nimodipine	Nimodipine	ANI Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9933	ORIG	2015-07-28