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ACYCLOVIR SODIUM

ANDA

ACYCLOVIR SODIUM | A205771 | HIKMA PHARMACEUTICALS LLC

2 strengths0 unique patents0 unique exclusivities

API Supply Chain3 active DMFs

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

EXCELLA GMBH AND CO KGACYCLOVIR SODIUM

DMF 109451994

SOLARA ACTIVE PHARMA SCIENCES LTDACYCLOVIR SODIUM

DMF 242892010

RAJASTHAN ANTIBIOTICS LTDACYCLOVIR SODIUM (STERILE)

DMF 408662024

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 4, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 500MG BASE/VIAL

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Feb 29, 2016

No patent or exclusivity listings for this strength.

#002 — EQ 1GM BASE/VIAL

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Feb 29, 2016