Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211027
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HALCINONIDE HALCINONIDE 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
08/12/2019 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211027Orig1s000ltr.pdf

HALCINONIDE

CREAM;TOPICAL; 0.1%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HALCINONIDE HALCINONIDE 0.1% CREAM;TOPICAL Prescription No AB 211027 MYLAN
HALOG HALCINONIDE 0.1% CREAM;TOPICAL Prescription Yes AB 017556 SUN PHARM INDS INC

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