Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 208324
Company: ALEMBIC PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE 10MG TABLET, ORALLY DISINTEGRATING;ORAL 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
11/16/2018 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208324Orig1s000ltr.pdf

VARDENAFIL HYDROCHLORIDE

TABLET, ORALLY DISINTEGRATING;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
STAXYN VARDENAFIL HYDROCHLORIDE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 200179 BAYER HLTHCARE
VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 208324 ALEMBIC PHARMS LTD

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