Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074331
Company: ACP NIMBLE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SOLUTION;TOPICAL Prescription AT 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
12/15/1995 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
03/11/2004 SUPPL-12 Labeling

Label is not available on this site.

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

Label is not available on this site.

10/31/2000 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

10/31/2000 SUPPL-8 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/15/1997 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/18/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/18/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/18/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/25/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

CLOBETASOL PROPIONATE

SOLUTION;TOPICAL; 0.05%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SOLUTION;TOPICAL Prescription No AT 074331 ACP NIMBLE
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SOLUTION;TOPICAL Prescription No AT 212881 ALEOR DERMACEUTICALS
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SOLUTION;TOPICAL Prescription No AT 075391 FOUGERA PHARMS
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SOLUTION;TOPICAL Prescription No AT 210190 GLENMARK PHARMS LTD
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SOLUTION;TOPICAL Prescription No AT 209361 MACLEODS PHARMS LTD
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SOLUTION;TOPICAL Prescription No AT 206075 NOVEL LABS INC
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SOLUTION;TOPICAL Prescription No AT 211494 SAPTALIS PHARMS
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SOLUTION;TOPICAL Prescription No AT 075224 TARO
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SOLUTION;TOPICAL Prescription No AT 075363 TARO
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SOLUTION;TOPICAL Prescription No AT 076977 TOLMAR
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SOLUTION;TOPICAL Prescription No AT 075205 WOCKHARDT BIO AG
EMBELINE CLOBETASOL PROPIONATE 0.05% SOLUTION;TOPICAL Prescription No AT 074222 HI TECH PHARMA

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