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ECONAZOLE NITRATE

ANDA

ECONAZOLE NITRATE | A076075 | CHARTWELL RX SCIENCES LLC

1 strength0 unique patents0 unique exclusivities

API Supply Chain4 active DMFs6 inactive

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

FDC LTDECONAZOLE NITRATE USP

DMF 104561993

YUNG ZIP CHEMICAL IND CO LTDECONAZOLE NITRATE

DMF 111401994

OLON SPAECONAZOLE NITRATE

DMF 128571998

PMC ISOCHEMECONAZOLE NITRATE

DMF 268722013

CILAG CHEMIE AGInactiveECONAZOLE NITRATE

DMF 28771977

ERREGIERRE SPAInactiveECONAZOLE NITRATE

DMF 68691987

INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE SPAInactiveECONAZOLE NITRATE

DMF 75471988

GUANGDONG PHARMACEUTICAL FACTORYInactiveECONAZOLE NITRATE

DMF 113031994

GUFIC BIOSCIENCES LTDInactiveECONAZOLE NITRATE USP

DMF 127991997

SIFAVITOR SRLInactiveECONAZOLE

DMF 142371999

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 13, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1%

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Nov 26, 2002

No patent or exclusivity listings for this strength.