Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074407
Company: FOUGERA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% OINTMENT;TOPICAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/23/1996 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.

03/05/2001 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/05/2001 SUPPL-3 Labeling

Label is not available on this site.

05/08/1997 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

OINTMENT;TOPICAL; 0.05%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% OINTMENT;TOPICAL Prescription No AB 074089 ACP NIMBLE
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% OINTMENT;TOPICAL Prescription No AB 211800 ALEOR DERMACEUTICALS
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% OINTMENT;TOPICAL Prescription No AB 074407 FOUGERA PHARMS
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% OINTMENT;TOPICAL Prescription No AB 208933 GLENMARK PHARMS
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% OINTMENT;TOPICAL Prescription No AB 075057 MYLAN
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% OINTMENT;TOPICAL Prescription No AB 208841 NOVEL LABS INC
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% OINTMENT;TOPICAL Prescription No AB 074248 TARO
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% OINTMENT;TOPICAL Prescription No AB 208589 TELIGENT PHARMA INC
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% OINTMENT;TOPICAL Prescription No AB 212926 TORRENT
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% OINTMENT;TOPICAL Prescription No AB 209701 XIROMED
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% OINTMENT;TOPICAL Prescription No AB 210199 ZYDUS PHARMS
EMBELINE CLOBETASOL PROPIONATE 0.05% OINTMENT;TOPICAL Prescription No AB 074221 HI TECH PHARMA

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