Application 077067

Type: ANDA
Sponsor: SUN PHARM INDS INC

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 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
A077067-001	NIMODIPINE	NIMODIPINE	30MG	CAPSULE / ORAL			2007-04-17

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.

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
2026-08-01 22:54:32	2026-06	A077067-001	NIMODIPINE	30MG	CAPSULE / ORAL			2007-04-17	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
57664-135	Nimodipine	Nimodipine	Caraco Pharmaceutical Laboratories, Ltd.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9000	ORIG	2007-04-25