Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203753
Company: MYLAN TECHNOLOGIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SCOPOLAMINE SCOPOLAMINE 1MG/72HR SYSTEM;TRANSDERMAL 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
06/19/2019 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/203753Orig1s000ChemR.pdf

SCOPOLAMINE

SYSTEM;TRANSDERMAL; 1MG/72HR
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SCOPOLAMINE SCOPOLAMINE 1MG/72HR SYSTEM;TRANSDERMAL Prescription No AB 203753 MYLAN TECHNOLOGIES
SCOPOLAMINE SCOPOLAMINE 1MG/72HR SYSTEM;TRANSDERMAL Prescription No AB 078830 PERRIGO PHARMS CO
SCOPOLAMINE SCOPOLAMINE 1MG/72HR SYSTEM;TRANSDERMAL Prescription No AB 212342 RICONPHARMA LLC
TRANSDERM SCOP SCOPOLAMINE 1MG/72HR SYSTEM;TRANSDERMAL Prescription Yes AB 017874 BAXTER HLTHCARE CORP

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