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BUMETANIDE

ANDA

BUMETANIDE | A209724 | AMNEAL PHARMACEUTICALS CO GMBH

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: BUMEX(TE code: AB)

API Supply Chain8 active DMFs2 inactive

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

GUILIN PHARMACEUTICAL CO LTDBUMETANIDE USP

DMF 86821990

OLON SPABUMETANIDE

DMF 109941994

INDUSTRIALE CHIMICA SRLBUMETANIDE

DMF 247502011

SOLARA ACTIVE PHARMA SCIENCES LTDBUMETANIDE USP

DMF 332612018

MSN LABORATORIES PRIVATE LTDBUMETANIDE USP

DMF 339152019

HAINAN POLY PHARM CO LTDBUMETANIDE USP

DMF 402722024

MEDILUX LABORATORIES PVT LTDBUMETANIDE USP

DMF 418302025

UNICHEM LABORATORIES LTDBUMETANIDE USP

DMF 420472025

QUIMICA SINTETICA SAInactiveBUMETANIDE

DMF 84351990

LEO PHARMACEUTICAL PRODUCTS LTDInactiveBUMETANIDE PURE MICRONISED

DMF 127021997

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

Products (3)

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#001 — 0.5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Oct 18, 2017

No patent or exclusivity listings for this strength.

#002 — 1MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 18, 2017

#003 — 2MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 18, 2017