Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076493
Company: TARO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE EQ 0.05% BASE;1% LOTION;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
07/28/2004 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76493ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/23/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

01/29/2009 SUPPL-4 Labeling

Label is not available on this site.

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE

LOTION;TOPICAL; EQ 0.05% BASE;1%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE EQ 0.05% BASE;1% LOTION;TOPICAL Prescription No AB 076516 FOUGERA PHARMS
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE EQ 0.05% BASE;1% LOTION;TOPICAL Prescription No AB 076493 TARO
LOTRISONE BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE EQ 0.05% BASE;1% LOTION;TOPICAL Prescription Yes AB 020010 MERCK SHARP DOHME

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