Viewing data from:

VARDENAFIL HYDROCHLORIDE

ANDA

VARDENAFIL HYDROCHLORIDE | A208324 | ALEMBIC PHARMACEUTICALS LTD

1 strength0 unique patents0 unique exclusivities

API Supply Chain7 active DMFs1 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

ZAKLADY FARMACEUTYCZNE POLPHARMA SAVARDENAFIL HYDROCHLORIDE TRIHYDRATE

DMF 251742011

MACLEODS PHARMACEUTICALS LTDVARDENAFIL HYDROCHLORIDE TRIHYDRATE

DMF 257952012

ALEMBIC PHARMACEUTICALS LTDVARDENAFIL HYDROCHLORIDE USP

DMF 289002014

RAKS PHARMA PVT LTDVARDENAFIL HYDROCHLORIDE TRIHYDRATE USP

DMF 308042016

SMS PHARMACEUTICALS LTDVARDENAFIL HYDROCHLORIDE TRIHYDRATE USP

DMF 329082018

CHROMO LABORATORIES INDIA PRIVATE LTDVARDENAFIL HYDROCHLORIDE TRIHYDRATE USP

DMF 332202019

RAKSHIT PHARMACEUTICALS LTDVARDENAFIL HYDROCHLORIDE

DMF 434092025

DR REDDYS LABORATORIES LTDInactiveVARDENAFIL HYDROCHLORIDE TRIHYDRATE

DMF 207802007

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 20, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG

0 patents0 exclusivities▴

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Nov 16, 2018

No patent or exclusivity listings for this strength.