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Not in the current Orange Book — This application is not listed in FDA's current Orange Book data files (no listed patents or exclusivities). Product and approval data shown are from FDA's Drugs@FDA database.

ISONIAZID

ANDANot in Orange Book

ISONIAZID | A087425 | HIKMA INTL PHARMS

API Supply Chain3 active DMFs2 inactive

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

YUKI GOSEI KOGYO CO LTDISONIAZID BULK FORM

DMF 47721982

YANGZHOU PHARMACEUTICAL CO LTDISONIAZID

DMF 162352002

CALYX CHEMICALS AND PHARMACEUTICALS LTDISONIAZID

DMF 213222008

BAYER CORPInactiveISONIAZID (NEOTEBEN)

DMF 58901985

BEIJING SECOND PHARMACEUTICAL FACTORYInactiveISONIAZID USP23

DMF 146622000

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

Products (1)

#001 — 300MG

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TABLET;ORAL | Approved: Jul. 14, 1981

No patent or exclusivity listings for this strength.