Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074139
Company: ACP NIMBLE
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
08/03/1994 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
04/08/2005 SUPPL-17 Labeling

Label is not available on this site.

10/02/2002 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

09/28/2001 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

09/28/2001 SUPPL-14 Labeling

Label is not available on this site.

09/28/2001 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/31/2002 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

05/31/2002 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/29/2000 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

08/18/1999 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/07/1998 SUPPL-8 Labeling

Label is not available on this site.

06/28/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/16/1996 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/16/1996 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/16/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/16/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/05/1995 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/13/1995 SUPPL-1 Manufacturing (CMC)

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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