An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 210629
Company: LUPIN

Products on ANDA 210629

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CYANOCOBALAMIN	CYANOCOBALAMIN	0.5MG/SPRAY	SPRAY, METERED;NASAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210629

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/30/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 210629

CYANOCOBALAMIN

SPRAY, METERED;NASAL; 0.5MG/SPRAY
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CYANOCOBALAMIN	CYANOCOBALAMIN	0.5MG/SPRAY	SPRAY, METERED;NASAL	Prescription	No	AB	210629	LUPIN
CYANOCOBALAMIN	CYANOCOBALAMIN	0.5MG/SPRAY	SPRAY, METERED;NASAL	Prescription	No	AB	212458	PADAGIS ISRAEL
NASCOBAL	CYANOCOBALAMIN	0.5MG/SPRAY	SPRAY, METERED;NASAL	Prescription	Yes	AB	021642	ENDO PHARMS INC

Top