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Details for New Drug Application (NDA): 080003

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NDA 080003 describes NITROFURANTOIN, which is a drug marketed by Elkins Sinn, Sun Pharm Inds, Mylan, Watson Labs, Sandoz, Impax Labs Inc, Nostrum Labs Inc, Ivax Sub Teva Pharms, Amneal Pharms, Actavis Mid Atlantic, Whiteworth Town Plsn, Novel Labs Inc, Actavis Labs Fl Inc, Watson Labs Inc, and Ranbaxy Labs Ltd, and is included in twenty-six NDAs. It is available from twenty-three suppliers. Additional details are available on the NITROFURANTOIN profile page.

The generic ingredient in NITROFURANTOIN is nitrofurantoin; nitrofurantoin, macrocrystalline. There are nineteen drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the nitrofurantoin; nitrofurantoin, macrocrystalline profile page.

Summary for NDA: 080003

Elkins Sinn
Therapeutic Class:Antibacterials

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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