Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202894
Company: GLENMARK PHARMS
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% CREAM;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
10/30/2015 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/13/2016 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE

CREAM;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% CREAM;TOPICAL Prescription No AB 076002 ACTAVIS MID ATLANTIC
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE EQ 0.05% BASE;1% CREAM;TOPICAL Prescription No AB 075502 FOUGERA PHARMS
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE EQ 0.05% BASE;1% CREAM;TOPICAL Prescription No AB 202894 GLENMARK PHARMS
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE EQ 0.05% BASE;1% CREAM;TOPICAL Prescription No AB 075673 TARO
LOTRISONE BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE EQ 0.05% BASE;1% CREAM;TOPICAL Prescription Yes AB 018827 MERCK SHARP DOHME

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