Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 201615
Company: TOLMAR
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% OINTMENT;TOPICAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/14/2013 ORIG-1 Approval Not Applicable Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201615Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/30/2019 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

10/14/2015 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

10/14/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

10/14/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE

OINTMENT;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% OINTMENT;TOPICAL Prescription No AB 200174 PERRIGO UK FINCO
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE 0.064%;0.005% OINTMENT;TOPICAL Prescription No AB 201615 TOLMAR
TACLONEX BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE 0.064%;0.005% OINTMENT;TOPICAL Prescription Yes AB 021852 LEO PHARMA AS

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