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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 212361

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NDA 212361 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-seven 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 212361

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

Pharmacology for NDA: 212361

Mechanism of Action	DNA Polymerase Inhibitors

Medical Subject Heading (MeSH) Categories for 212361

Antiviral Agents

Suppliers and Packaging for NDA: 212361

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACYCLOVIR	acyclovir	CREAM;TOPICAL	212361	ANDA	Alembic Pharmaceuticals Inc.	62332-423	62332-423-05	1 TUBE in 1 CARTON (62332-423-05) / 5 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	5%
Approval Date:	Nov 21, 2023	TE:	AB	RLD:	No
Regulatory Exclusivity Expiration:	Jun 12, 2024
Regulatory Exclusivity Use:	COMPETITIVE GENERIC THERAPY

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