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EPOPROSTENOL SODIUM

ANDA

EPOPROSTENOL SODIUM | A210473 | SUN PHARMACEUTICAL INDUSTRIES LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: VELETRI(TE code: AP2)

API Supply Chain4 active DMFs2 inactive

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

PHARMACIA AND UPJOHN SUB PFIZER INCEPOPROSTENOL SODIUM (U-53,217A)

DMF 60651985

CAYMAN PHARMA SROEPOPROSTENOL SODIUM

DMF 215842008

MSN LABORATORIES PRIVATE LTDEPOPROSTENOL SODIUM [ROUTE CODE - ED]

DMF 274202013

SUN PHARMACEUTICAL INDUSTRIES LTDEPOPROSTENOL SODIUM

DMF 302632017

JOHNSON MATTHEY PHARMA SERVICESInactiveEPOPROSTENOL SODIUM

DMF 180192005

EVERLIGHT CHEMICAL INDUSTRIAL CORPInactiveEPOPROSTENOL SODIUM

DMF 213112008

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 2, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 0.5MG BASE/VIAL

AP2

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jan 15, 2021

No patent or exclusivity listings for this strength.

#002 — EQ 1.5MG BASE/VIAL

AP2

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jan 15, 2021