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): 078337
Company: PADAGIS ISRAEL

Products on ANDA 078337

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BETAMETHASONE VALERATE	BETAMETHASONE VALERATE	0.12%	AEROSOL, FOAM;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078337

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/26/2012	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/078337Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 078337

BETAMETHASONE VALERATE

AEROSOL, FOAM;TOPICAL; 0.12%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BETAMETHASONE VALERATE	BETAMETHASONE VALERATE	0.12%	AEROSOL, FOAM;TOPICAL	Prescription	No	AB	078337	PADAGIS ISRAEL
BETAMETHASONE VALERATE	BETAMETHASONE VALERATE	0.12%	AEROSOL, FOAM;TOPICAL	Prescription	No	AB	208204	TARO
BETAMETHASONE VALERATE	BETAMETHASONE VALERATE	0.12%	AEROSOL, FOAM;TOPICAL	Prescription	No	AB	210639	XIROMED

Top