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ISOSORBIDE MONONITRATE

ANDA

ISOSORBIDE MONONITRATE | A076813 | HIKMA INTERNATIONAL PHARMACEUTICALS LLC

2 strengths0 unique patents0 unique exclusivities

API Supply Chain0 active DMFs1 inactive

0 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

SHANDONG NEW TIME PHARMACEUTICAL CO LTDInactiveISOSORBIDE MONONITRATE (NON-STERILE, BULK FORM)

DMF 208162007

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

Products (2)

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#001 — 60MG

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Jan 7, 2005

No patent or exclusivity listings for this strength.

#002 — 30MG

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Mar 30, 2006