Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075430
Company: FOUGERA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLOBETASOL PROPIONATE (EMOLLIENT) CLOBETASOL PROPIONATE 0.05% CREAM;TOPICAL Prescription AB2 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
05/26/1999 ORIG-1 Approval Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75430ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75-430_clobetasol.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/21/2018 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

03/16/2007 SUPPL-4 Labeling

Label is not available on this site.

06/14/1999 SUPPL-1 Labeling

Label is not available on this site.

CLOBETASOL PROPIONATE (EMOLLIENT)

CREAM;TOPICAL; 0.05%
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOBETASOL PROPIONATE (EMOLLIENT) CLOBETASOL PROPIONATE 0.05% CREAM;TOPICAL Prescription No AB2 075733 ANI PHARMS INC
CLOBETASOL PROPIONATE (EMOLLIENT) CLOBETASOL PROPIONATE 0.05% CREAM;TOPICAL Prescription No AB2 075430 FOUGERA PHARMS
CLOBETASOL PROPIONATE (EMOLLIENT) CLOBETASOL PROPIONATE 0.05% CREAM;TOPICAL Prescription No AB2 075633 TARO
CLOBETASOL PROPIONATE (EMOLLIENT) CLOBETASOL PROPIONATE 0.05% CREAM;TOPICAL Prescription No AB2 209411 TELIGENT PHARMA INC
EMBELINE E CLOBETASOL PROPIONATE 0.05% CREAM;TOPICAL Prescription No AB2 075325 HI TECH PHARMA

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