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Details for New Drug Application (NDA): 075669

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NDA 075669 describes FAMOTIDINE PRESERVATIVE FREE, which is a drug marketed by Apothecon, Fresenius Kabi Usa, Amphastar Pharms Inc, Apotex Inc, Mylan Labs Ltd, Hospira, Eurohlth Intl Sarl, Abbvie, and Baxter Hlthcare, and is included in twelve NDAs. It is available from five suppliers. Additional details are available on the FAMOTIDINE PRESERVATIVE FREE profile page.

The generic ingredient in FAMOTIDINE PRESERVATIVE FREE is famotidine. There are eighteen drug master file entries for this compound. One hundred and nineteen suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the famotidine profile page.

Summary for NDA: 075669

Therapeutic Class:Gastrointestinal Agents

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Apr 16, 2001TE:RLD:No

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