Viewing data from:

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.

DANAZOL

ANDANot in Orange Book

DANAZOL | A078214 | LANNETT

API Supply Chain1 active DMF7 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

CIPLA LTDDANAZOL USP

DMF 56161984

NV ORGANONInactiveDANAZOL

DMF 47401982

HOVIONE SOCIEDADE QUIMICA LDAInactiveDANAZOL

DMF 62871986

FINE CHEMICALS CORPInactiveDANAZOL USP

DMF 63901986

SCHERING AGInactiveDANAZOL

DMF 75841988

PROQUINA SAInactiveDANAZOL

DMF 76041988

RECORDATI CORPInactiveDANAZOL

DMF 79711989

PRODUCTOS QUIMICOS NATURALES SA DE CVInactiveDANAZOL

DMF 240212010

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

Products (2)

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#001 — 50MG

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CAPSULE;ORAL | Approved: Apr. 19, 2007

No patent or exclusivity listings for this strength.

#002 — 100MG

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CAPSULE;ORAL | Approved: Apr. 19, 2007