Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210191
Company: TARO PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DAPSONE DAPSONE 7.5% GEL;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
06/26/2019 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210191Orig1s000ltr.pdf

DAPSONE

GEL;TOPICAL; 7.5%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACZONE DAPSONE 7.5% GEL;TOPICAL Prescription Yes AB 207154 ALMIRALL
DAPSONE DAPSONE 7.5% GEL;TOPICAL Prescription No AB 210191 TARO PHARMS

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