Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075502
Company: FOUGERA 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
06/05/2001 ORIG-1 Approval Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75502ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-502_Clotrimazole.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/11/2015 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

09/11/2015 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

06/26/2003 SUPPL-1 Labeling

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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