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): 078468
Company: COSETTE

Products on ANDA 078468

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CALCIPOTRIENE	CALCIPOTRIENE	0.005%	SOLUTION;TOPICAL	Prescription	AT	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078468

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/24/2011	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Therapeutic Equivalents for ANDA 078468

CALCIPOTRIENE

SOLUTION;TOPICAL; 0.005%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CALCIPOTRIENE	CALCIPOTRIENE	0.005%	SOLUTION;TOPICAL	Prescription	No	AT	207163	CHARTWELL RX
CALCIPOTRIENE	CALCIPOTRIENE	0.005%	SOLUTION;TOPICAL	Prescription	No	AT	078468	COSETTE
CALCIPOTRIENE	CALCIPOTRIENE	0.005%	SOLUTION;TOPICAL	Prescription	No	AT	078305	FOUGERA PHARMS

Top