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): 207094
Company: SAPTALIS PHARMS

Products on ANDA 207094

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.147MG/GM	SPRAY;TOPICAL	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207094

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/07/2016	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 207094

TRIAMCINOLONE ACETONIDE

SPRAY;TOPICAL; 0.147MG/GM
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.147MG/GM	SPRAY;TOPICAL	Prescription	No	AT	205782	PADAGIS ISRAEL
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.147MG/GM	SPRAY;TOPICAL	Prescription	No	AT	206786	RISING
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.147MG/GM	SPRAY;TOPICAL	Prescription	No	AT	207094	SAPTALIS PHARMS

Top