Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091347
Company: TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE 2.5MG TABLET;ORAL Prescription AB No No
VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription AB No No
VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription AB No No
VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE 20MG TABLET;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
05/03/2012 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/09/2015 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

10/30/2012 SUPPL-1 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

VARDENAFIL HYDROCHLORIDE

TABLET;ORAL; 2.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE 2.5MG TABLET;ORAL Prescription No AB 209057 CROSSMEDIKA SA
VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE 2.5MG TABLET;ORAL Prescription No AB 204632 MACLEODS PHARMS LTD
VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE 2.5MG TABLET;ORAL Prescription No AB 091347 TEVA PHARMS
VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE 2.5MG TABLET;ORAL Prescription No AB 208960 ZYDUS PHARMS

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVITRA VARDENAFIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription Yes AB 021400 BAYER HLTHCARE
VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 209057 CROSSMEDIKA SA
VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 204632 MACLEODS PHARMS LTD
VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 091347 TEVA PHARMS
VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 208960 ZYDUS PHARMS

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVITRA VARDENAFIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription Yes AB 021400 BAYER HLTHCARE
VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 209057 CROSSMEDIKA SA
VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 204632 MACLEODS PHARMS LTD
VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 091347 TEVA PHARMS
VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 208960 ZYDUS PHARMS

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVITRA VARDENAFIL HYDROCHLORIDE 20MG TABLET;ORAL Prescription Yes AB 021400 BAYER HLTHCARE
VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 209057 CROSSMEDIKA SA
VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 204632 MACLEODS PHARMS LTD
VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 091347 TEVA PHARMS
VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 208960 ZYDUS PHARMS

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