Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074089
Company: ACP NIMBLE
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 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
02/16/1994 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
01/04/2016 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

11/26/2004 SUPPL-20 Labeling

Label is not available on this site.

10/31/2001 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.

10/31/2001 SUPPL-12 Manufacturing (CMC)-Facility

Label is not available on this site.

10/31/2001 SUPPL-11 Manufacturing (CMC)-Facility

Label is not available on this site.

01/23/2002 SUPPL-10 Manufacturing (CMC)-Facility

Label is not available on this site.

02/26/2001 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.

03/23/1999 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

09/09/1997 SUPPL-7 Labeling

Label is not available on this site.

03/27/1997 SUPPL-6 Labeling

Label is not available on this site.

06/13/1996 SUPPL-5 Labeling

Label is not available on this site.

03/18/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/31/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/23/1996 SUPPL-2 Manufacturing (CMC)

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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