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SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE

ANDA

SODIUM FERRIC GLUCONATE COMPLEX | A078215 | HIKMA PHARMACEUTICALS USA INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: FERRLECIT(TE code: AB)

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Watson Pharma, Inc. FDA-2004-P-0494 Watson Pharma, Inc. filed this citizen petition in February 2004 requesting that the FDA withhold approval of any Abbreviated New Drug Application for generic sodium ferric gluconate complex in sucrose (Ferrlecit®) unless the generic product is manufactured using the identical process as Watson's pr	505(q)	2009-08-10	Partially Denied	Watson Pharma

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

API Supply Chain3 active DMFs3 inactive

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

BIOFER SPASODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE

DMF 177462004

NAVINTA LLCSODIUM FERRIC GLUCONATE COMPLEX

DMF 185412005

MATRIX PHARMACORP PRIVATE LTDSODIUM FERRIC GLUCONATE COMPLEX

DMF 342282019

CILAG AGInactiveSODIUM FERRIC GLUCONATE

DMF 176022004

OPOCRIN SPAInactiveSODIUM FERRIC GLUCONATE

DMF 176452004

EMCURE PHARMACEUTICALS LTDInactiveSODIUM FERRIC GLUCONATE COMPLEX

DMF 219832008

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 4, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Mar 31, 2011

No patent or exclusivity listings for this strength.