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VARDENAFIL HYDROCHLORIDE

ANDA

VARDENAFIL HYDROCHLORIDE | A204632 | MACLEODS PHARMACEUTICALS LTD

4 strengths0 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.

Products (4)

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#001 — EQ 2.5MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Oct 22, 2019

No patent or exclusivity listings for this strength.

#002 — EQ 5MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 22, 2019

#003 — EQ 10MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 22, 2019

#004 — EQ 20MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 22, 2019