This site is intended for healthcare professionals
Abstract digital waveforms in blue and purple
  • Home
  • /
  • Drugs
  • /
  • V
  • /
  • VARDENAFIL
  • /
  • VARDENAFIL VARDENAFIL HYDROCHLORIDE TRIHYDRATE 10 mg/1 Zydus Lifesciences Limited
FDA Drug information

VARDENAFIL

Read time: 1 mins
Marketing start date: 23 Dec 2024
...
 

Summary of product characteristics


Effective Time

20221031

Version

4

Spl Product Data Elements

VARDENAFIL VARDENAFIL VARDENAFIL HYDROCHLORIDE TRIHYDRATE VARDENAFIL CELLULOSE, MICROCRYSTALLINE HYPROMELLOSES POLYETHYLENE GLYCOL, UNSPECIFIED SILICON DIOXIDE SODIUM STEARYL FUMARATE STARCH, CORN TITANIUM DIOXIDE WHITE TO OFF-WHITE ROUND 10;68 VARDENAFIL VARDENAFIL VARDENAFIL HYDROCHLORIDE TRIHYDRATE VARDENAFIL CELLULOSE, MICROCRYSTALLINE FERRIC OXIDE RED FERRIC OXIDE YELLOW HYPROMELLOSES POLYETHYLENE GLYCOL, UNSPECIFIED SILICON DIOXIDE SODIUM STEARYL FUMARATE STARCH, CORN TITANIUM DIOXIDE LIGHT YELLOW ROUND 10;69 VARDENAFIL VARDENAFIL VARDENAFIL HYDROCHLORIDE TRIHYDRATE VARDENAFIL CELLULOSE, MICROCRYSTALLINE FERRIC OXIDE RED FERRIC OXIDE YELLOW HYPROMELLOSES POLYETHYLENE GLYCOL, UNSPECIFIED SILICON DIOXIDE SODIUM STEARYL FUMARATE STARCH, CORN TITANIUM DIOXIDE LIGHT YELLOW TO ORANGE ROUND 10;70 VARDENAFIL VARDENAFIL VARDENAFIL HYDROCHLORIDE TRIHYDRATE VARDENAFIL CELLULOSE, MICROCRYSTALLINE FERRIC OXIDE RED FERRIC OXIDE YELLOW HYPROMELLOSES POLYETHYLENE GLYCOL, UNSPECIFIED SILICON DIOXIDE SODIUM STEARYL FUMARATE STARCH, CORN TITANIUM DIOXIDE LIGHT YELLOW TO ORANGE ROUND 10;71

Application Number

ANDA208960

Brand Name

VARDENAFIL

Generic Name

VARDENAFIL

Product Ndc

70771-1049

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1047-3 Vardenafil Tablets, 2.5 mg 30 Tablets Rx only NDC 70771-1048-3 Vardenafil Tablets, 5 mg 30 Tablets Rx only NDC 70771-1049-3 Vardenafil Tablets, 10 mg 30 Tablets Rx only NDC 70771-1050-3 Vardenafil Tablets, 20 mg 30 Tablets Rx only Vardenafil Tablets Vardenafil Tablets Vardenafil Tablets Vardenafil Tablets

Drug section

CME banner

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.

Click here to view

Disclaimer

The drug Prescribing Information (PI), including indications, contra-indications, interactions, etc, has been developed using the U.S. Food & Drug Administration (FDA) as a source (www.fda.gov).

Medthority offers the whole library of PI documents from the FDA. Medthority will not be held liable for explicit or implicit errors, or missing data.

Drugs appearing in this section are approved by the FDA. For regions outside of the United States, this content is for informational purposes only and may not be aligned with local regulatory approvals or guidance.