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Serving leading biopharmaceutical companies globally:

Julphar
Dow
Merck
Deloitte
US Department of Justice
Teva
Boehringer Ingelheim
Cipla
Express Scripts
Covington

Generated: October 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074509

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NDA 074509 describes AMANTADINE HYDROCHLORIDE, which is a drug marketed by Watson Labs Inc, Pharm Assoc, Teva Pharms, Cmp Pharma Inc, Bionpharma Inc, Lannett Holdings Inc, Mikart, Strides Pharma, Silarx, G And W Labs Inc, Actavis Elizabeth, Wockhardt, Alembic Pharms Ltd, Newgen Pharms Llc, Hi Tech Pharma, Heritage Pharma, Zydus Pharms Usa Inc, Watson Labs, Usl Pharma, Vintage, and Sandoz, and is included in twenty-five NDAs. It is available from forty-three suppliers. Additional details are available on the AMANTADINE HYDROCHLORIDE profile page.

The generic ingredient in AMANTADINE HYDROCHLORIDE is amantadine hydrochloride. There are seven drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the amantadine hydrochloride profile page.

Summary for NDA: 074509

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antiparkinson Agents
Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 074509

Mechanism of ActionM2 Protein Inhibitors

Suppliers and Packaging for NDA: 074509

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMANTADINE HYDROCHLORIDE
amantadine hydrochloride
SYRUP;ORAL 074509 ANDA Pharmaceutical Associates, Inc. 0121-0646 0121-0646-10 10 TRAY in 1 CASE (0121-0646-10) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE
AMANTADINE HYDROCHLORIDE
amantadine hydrochloride
SYRUP;ORAL 074509 ANDA Pharmaceutical Associates, Inc. 0121-0646 0121-0646-16 473 mL in 1 BOTTLE (0121-0646-16)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength50MG/5ML
Approval Date:Jul 17, 1995TE:AARLD:No


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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Daiichi Sankyo
Healthtrust
Moodys
US Department of Justice
Fish and Richardson
Teva
Mallinckrodt
Accenture
Citi

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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