Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210765
Company: COSETTE

Products on ANDA 210765

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE	0.064%;0.005%	SUSPENSION;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210765

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/11/2020	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210765Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 210765

CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE

SUSPENSION;TOPICAL; 0.064%;0.005%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE	0.064%;0.005%	SUSPENSION;TOPICAL	Prescription	No	AB	210765	COSETTE
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE	0.064%;0.005%	SUSPENSION;TOPICAL	Prescription	No	AB	213269	TARO
TACLONEX	BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE	0.064%;0.005%	SUSPENSION;TOPICAL	Prescription	Yes	AB	022185	LEO PHARMA AS