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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206370
Company: TARO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLOCORTOLONE PIVALATE CLOCORTOLONE PIVALATE 0.1% CREAM;TOPICAL Prescription AB 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
04/21/2020 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/206370Orig1s000ltr.pdf

CLOCORTOLONE PIVALATE

CREAM;TOPICAL; 0.1%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOCORTOLONE PIVALATE CLOCORTOLONE PIVALATE 0.1% CREAM;TOPICAL Prescription No AB 206370 TARO
CLODERM CLOCORTOLONE PIVALATE 0.1% CREAM;TOPICAL Prescription Yes AB 017765 EPI HLTH
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