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Serving 500+ biopharmaceutical companies globally:

UBS
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Generated: June 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074980

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NDA 074980 describes ACYCLOVIR, which is a drug marketed by Watson Labs, Amneal Pharms, Actavis Elizabeth, Apotex Inc, Mylan Pharms Inc, Zydus Pharms Usa Inc, Teva Pharms, Abbvie, Hi Tech Pharma, Mylan, Teva, Dava Pharms Inc, Fougera Pharms Inc, Chartwell Molecules, Hetero Labs Ltd V, Ivax Sub Teva Pharms, Actavis Mid Atlantic, Cadila Pharms Ltd, Lek Pharm, Taro, Roxane, Ranbaxy, Sun Pharm Inds Ltd, Carlsbad, Heritage Pharms Inc, Boscogen, Eurohlth Intl Sarl, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Hospira, Mylan Labs Ltd, Teva Parenteral, Hikma Pharms Llc, Athenex Inc, and Apothecon, and is included in fifty-seven NDAs. It is available from fifty-seven 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: 074980

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 074980

Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors

Suppliers and Packaging for NDA: 074980

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACYCLOVIR
acyclovir
TABLET;ORAL 074980 ANDA Major Pharmaceuticals 0904-6121 0904-6121-61 100 TABLET in 1 BOTTLE, UNIT-DOSE (0904-6121-61)
ACYCLOVIR
acyclovir
TABLET;ORAL 074980 ANDA Blenheim Pharmacal, Inc. 10544-039 10544-039-25 25 TABLET in 1 BOTTLE (10544-039-25)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength400MG
Approval Date:Sep 30, 1998TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength800MG
Approval Date:Sep 30, 1998TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

Merck
Citi
Medtronic
US Army
Julphar
Fuji
Covington
Mallinckrodt
Chinese Patent Office
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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