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FOSCARNET SODIUM

ANDA

FOSCARNET SODIUM | A077174 | HOSPIRA INC

2 strengths0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Apotex Corp. FDA-1998-P-0979 · 5 docket documents Apotex Corp. filed this citizen petition under section 505(j)(2)(c) of the Federal Food, Drug and Cosmetic Act requesting approval to submit an Abbreviated New Drug Application for Foscarnet Sodium Injection 12 mg/mL, a pre-diluted formulation of the reference listed drug Foscavir (foscarnet sodium)	Other	2017-04-18	Granted	Apotex Corp.

Source: Regulations.gov. FDA citizen petitions matched by application number.

API Supply Chain8 active DMFs2 inactive

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

TRIFARMA SPAFOSCARNET SODIUM

DMF 190852006

CHEM WERTH INCFOSCARNET SODIUM USP

DMF 289962015

LIANYUNGANG RUNZHONG PHARMACEUTICAL CO LTDFOSCARNET SODIUM, NON STERILE, BULK DRUG SUBSTANCE

DMF 290562015

GLAND PHARMA LTDFOSCARNET SODIUM USP

DMF 298142015

EMCURE PHARMACEUTICALS LTDFOSCARNET SODIUM USP

DMF 326522018

BEIJING SCIECURE PHARMACEUTICAL CO LTDFOSCARNET SODIUM

DMF 332882019

MAITHRI DRUGS PRIVATE LTDFOSCARNET SODIUM USP

DMF 349682020

APITORIA PHARMA PRIVATE LTDFOSCARNET SODIUM USP

DMF 350252020

ASTRA CLINICAL RESEARCH ASSOC INCInactiveFOSCARNET SODIUM INTRAVENOUS SOLUTION

DMF 60361985

JIANGSU TIANQING PHARMACEUTICAL FACTORYInactiveFOSCARNET SODIUM

DMF 113851995

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 7, 2005	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 6GM/250ML (24MG/ML)

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: May 31, 2005

No patent or exclusivity listings for this strength.

#002 — 12GM/500ML (24MG/ML)

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: May 31, 2005