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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 074556

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NDA 074556 describes ACYCLOVIR, which is a drug marketed by Actavis Elizabeth, Adaptis, Apotex, Aurobindo Pharma Usa, Cadila, Cadila Pharms Ltd, Carlsbad Technology, Chartwell Molecules, Heritage, Ivax Sub Teva Pharms, Lek Pharm, Mylan, Ranbaxy, Roxane, Strides Pharma, Teva, Teva Pharms, Watson Labs, Yiling, Alembic, Amneal, Padagis Israel, Taro, Zydus Lifesciences, Abbvie, Amneal Pharms, Anda Repository, Chartwell Rx, Cipla, Cosette, Fougera Pharms Inc, Glenmark Speclt, Macleods Pharms Ltd, Mylan Pharms Inc, Prinston Inc, Torrent, Xiromed, Actavis Mid Atlantic, Aurobindo Pharma, Hetero Labs Ltd Iii, Hikma, MSN, Novitium Pharma, Rubicon, Vistapharm Llc, Apotex Inc, Carlsbad, Hetero Labs Ltd V, Square Pharms, Sun Pharm Inds Ltd, Zydus Pharms, Eurohlth Intl Sarl, Apothecon, Chartwell Injectable, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hospira, Norvium Bioscience, Slate Run Pharma, and Teva Parenteral, and is included in ninety NDAs. It is available from sixty-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. Nine suppliers are listed for this compound. Additional details are available on the acyclovir sodium profile page.

Summary for 074556

Tradename:	ACYCLOVIR
Applicant:	Teva
Ingredient:	acyclovir
Patents:	0

Medical Subject Heading (MeSH) Categories for 074556

Antiviral Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Apr 22, 1997	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	400MG
Approval Date:	Apr 22, 1997	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	800MG
Approval Date:	Apr 22, 1997	TE:	AB	RLD:	No

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