Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074392
Company: FOUGERA PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% CREAM;TOPICAL Prescription AB1 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
09/30/1996 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
08/14/2006 SUPPL-7 Labeling

Label is not available on this site.

03/03/2000 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/03/2000 SUPPL-3 Labeling

Label is not available on this site.

12/15/1997 SUPPL-2 Labeling

Label is not available on this site.

12/15/1997 SUPPL-1 Labeling

Label is not available on this site.

CLOBETASOL PROPIONATE

CREAM;TOPICAL; 0.05%
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% CREAM;TOPICAL Prescription No AB1 074139 ACP NIMBLE
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% CREAM;TOPICAL Prescription No AB1 211256 AMNEAL PHARMS LLC
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% CREAM;TOPICAL Prescription No AB1 074392 FOUGERA PHARMS INC
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% CREAM;TOPICAL Prescription No AB1 209095 GLENMARK PHARMS
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% CREAM;TOPICAL Prescription No AB1 210208 LUPIN LTD
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% CREAM;TOPICAL Prescription No AB1 075338 MYLAN
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% CREAM;TOPICAL Prescription No AB1 211401 RISING
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% CREAM;TOPICAL Prescription No AB1 074249 TARO
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% CREAM;TOPICAL Prescription No AB1 209974 TELIGENT PHARMA INC
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% CREAM;TOPICAL Prescription No AB1 210034 XIROMED
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% CREAM;TOPICAL Prescription No AB1 211074 ZYDUS PHARMS
CORMAX CLOBETASOL PROPIONATE 0.05% CREAM;TOPICAL Prescription No AB1 074220 HI TECH PHARMA

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