Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075733
Company: NOVAST LABS
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 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
08/22/2001 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75733_Clobetasol Propionate_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75733_Clobetasol Propionate_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075733_clobetasol_propionate_toc.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/22/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75733_Clobetasol Propionate_Prntlbl.pdf

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 075430 FOUGERA PHARMS
CLOBETASOL PROPIONATE (EMOLLIENT) CLOBETASOL PROPIONATE 0.05% CREAM;TOPICAL Prescription No AB2 075733 NOVAST LABS
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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