Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 090633
Company: GLENMARK PHARMS INC

Products on ANDA 090633

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090633

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/24/2010	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090633ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/090633Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/24/2019	SUPPL-6	Labeling-Proprietary Name Change		Label is not available on this site.
05/24/2019	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
08/13/2015	SUPPL-1	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 090633

CALCIPOTRIENE

OINTMENT;TOPICAL; 0.005%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CALCIPOTRIENE	CALCIPOTRIENE	0.005%	OINTMENT;TOPICAL	Prescription	No	AB	090633	GLENMARK PHARMS INC
DOVONEX	CALCIPOTRIENE	0.005%	OINTMENT;TOPICAL	Prescription	Yes	AB	020273	LEO PHARMA AS