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Details for New Drug Application (NDA): 075114

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NDA 075114 describes ACYCLOVIR, which is a drug marketed by Watson Labs, Amneal Pharms, Actavis Elizabeth, Apotex Inc, Mylan, Zydus Pharms Usa Inc, Teva Pharms, Abbvie, Hi Tech Pharma, Teva, Dava Pharms Inc, Fougera Pharms Inc, Hetero Labs Ltd V, Ivax Sub Teva Pharms, Actavis Mid Atlantic, Cadila Pharms Ltd, Lek Pharm, Mylan Pharms Inc, Roxane, Ranbaxy, Sun Pharm Inds Ltd, Carlsbad, Heritage Pharms Inc, Stason, Eurohlth Intl Sarl, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Hospira, Teva Parenteral, Hikma Pharms Llc, Amphastar Pharms Inc, and Apothecon, and is included in fifty-four NDAs. It is available from fifty-five suppliers. Additional details are available on the ACYCLOVIR profile page.

The generic ingredient in ACYCLOVIR is acyclovir sodium. There are fifty-five drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the acyclovir sodium profile page.

Summary for NDA: 075114

acyclovir sodium

Summary for product number 001

Approval Date:Jul 26, 1999TE:RLD:No

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