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ISOSORBIDE DINITRATE

ANDA

ISOSORBIDE DINITRATE | A088088 | HIKMA INTERNATIONAL PHARMACEUTICALS LLC

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: ISORDIL(TE code: AB)

API Supply Chain2 active DMFs8 inactive

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

DIPHARMA FRANCIS SRLISOSORBIDE DINITRATE (ISDN)

DMF 37251980

EIRCHEM PHARMA SERVICES LTDISOSORBIDE DINITRATE DILUTED

DMF 92281991

NYSCO LABS INCInactiveISOSORBIDE DINITRATE TIMED RELEASE PELLETS

DMF 10211967

NAPP-LEMKE CHEMS INCInactiveISOSORBIDE DINITRATE

DMF 17911971

EUTICALS LTDInactiveISOSORBIDE DINITRATE BULK

DMF 18551972

PALMER RESEARCH LABORATORIESInactiveISOSORBIDE DINITRATE TRITURATE

DMF 18571972

BOFORS INDSInactiveISOSORBIDE DINITRATE

DMF 22381974

SANOL SCHWARZInactiveISOSORBIDE DINITRATE TRANSDERMAL SUSPENSION

DMF 42241981

LYPHOMED INCInactiveISOSORBIDE DINITRATE INJECTION (50ML AND 100ML)

DMF 57611985

INDUSTRIAS QUIMICAS TAUBATE SAInactiveISOSORBIDE DINITRATE

DMF 77071988

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

Products (3)

Sort:

#001 — 20MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 2, 1987

No patent or exclusivity listings for this strength.

#002 — 10MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 29, 1987

#003 — 5MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 29, 1987