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RIBAVIRIN

ANDA

RIBAVIRIN | A077094 | ZYDUS PHARMACEUTICALS USA INC

4 strengths0 unique patents0 unique exclusivities

API Supply Chain5 active DMFs8 inactive

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

SIEGFRIED EVIONNAZ SARIBAVIRIN

DMF 121561996

YUHAN CHEMICAL INCRIBAVIRIN USP, 1H-1,2,4-TRIAZOLE-3-CARBOXAMIDE, 1-BETA-D-RIBOFURANOSYL

DMF 156112001

CURIA ITALY SRLRIBAVIRIN USP-EP

DMF 157002001

APITORIA PHARMA PRIVATE LTDRIBAVIRIN USP

DMF 189732005

ZHEJIANG CHENG YI PHARMACEUTICAL CO LTDRIBAVIRIN

DMF 268452012

ORGAMOL SAInactiveRIBAVIRIN

DMF 56871985

HEINRICH MACK NACHFInactiveRIBAVIRIN

DMF 64961986

YAMASA CORPInactiveRIBAVIRIN

DMF 127661997

XINXIANG PHARMACEUTICAL CO LTDInactiveRIBAVIRIN NON-STERILE BULK FORM

DMF 156552001

BIDACHEM SPAInactiveRIBAVIRIN

DMF 157562001

ZHEJIANG CHENG YI PHARMACEUTICAL CO LTDInactiveRIBAVIRIN (NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT)

DMF 192132006

EUTICALS SPAInactiveRIBAVIRIN

DMF 230042009

ERREDUE SPA INNOVATIVE CHEMICAL AND LIFEInactiveRIBAVIRIN USP EP

DMF 230232009

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Oct 20, 2005	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 200MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 5, 2005

No patent or exclusivity listings for this strength.

#002 — 400MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 16, 2007

#003 — 600MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 16, 2007

#004 — 500MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 18, 2008