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Last Updated: April 21, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077309

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NDA 077309 describes ACYCLOVIR, which is a drug marketed by Actavis Elizabeth, Apotex, Cadila, Cadila Pharms Ltd, Carlsbad Technology, Chartwell Molecules, Dava Pharms Inc, Heritage Pharms Inc, Ivax Sub Teva Pharms, Kenton, Lek Pharm, Mylan, Ranbaxy, Roxane, Teva, Teva Pharms, Watson Labs, Yiling, Amneal, Perrigo Uk Finco, Abbvie, Alembic Pharms Ltd, Amneal Pharms, Anda Repository, Cipla, Cosette, Fougera Pharms Inc, Glenmark Pharms Sa, Mylan Pharms Inc, Solaris Pharma Corp, Taro, Torrent, Xiromed, Actavis Mid Atlantic, Akorn, Novitium Pharma, Apotex Inc, Carlsbad, Hetero Labs Ltd V, Square Pharms Ltd, Sun Pharm Inds Ltd, Zydus Pharms, Eurohlth Intl Sarl, Apothecon, Athenex Inc, Aurobindo Pharma Ltd, Exela Pharma, Fresenius Kabi Usa, Hikma, Hospira, Mylan Labs Ltd, and Teva Parenteral, and is included in seventy-eight NDAs. It is available from fifty-eight suppliers. Additional details are available on the ACYCLOVIR profile page.

The generic ingredient in ACYCLOVIR is acyclovir sodium. There are fifty-six 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 077309
Tradename:ACYCLOVIR
Applicant:Apotex Inc
Ingredient:acyclovir
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077309
Mechanism of ActionDNA Polymerase Inhibitors
Medical Subject Heading (MeSH) Categories for 077309
Suppliers and Packaging for NDA: 077309
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACYCLOVIR acyclovir TABLET;ORAL 077309 ANDA Major Pharmaceuticals 0904-5790 0904-5790-61 100 BLISTER PACK in 1 BOX, UNIT-DOSE (0904-5790-61) > 1 TABLET in 1 BLISTER PACK
ACYCLOVIR acyclovir TABLET;ORAL 077309 ANDA A-S Medication Solutions 50090-0637 50090-0637-0 35 TABLET in 1 BOTTLE (50090-0637-0)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Sep 29, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength800MG
Approval Date:Sep 29, 2005TE:ABRLD:No

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