Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074249
Company: TARO
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
07/08/1996 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
09/06/2019 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

11/07/2003 SUPPL-15 Labeling

Label is not available on this site.

12/23/2002 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

11/07/2002 SUPPL-12 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/11/2002 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

12/09/2002 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

12/09/2002 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

04/06/2000 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

02/11/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/19/1997 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/25/1997 SUPPL-5 Labeling

Label is not available on this site.

11/25/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/25/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/25/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/25/1997 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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