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Moodys
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Medtronic
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Covington
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Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075819

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NDA 075819 describes AMANTADINE HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Alembic Pharms Ltd, Bionpharma Inc, Heritage Pharma, Lannett Holdings Inc, Newgen Pharms Llc, Sandoz, Strides Pharma, Usl Pharma, Watson Labs, Watson Labs Inc, Zydus Pharms Usa Inc, Cmp Pharma Inc, G And W Labs Inc, Hi Tech Pharma, Mikart, Pharm Assoc, Silarx, Teva Pharms, Vintage, and Wockhardt, and is included in twenty-five NDAs. It is available from forty-two 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-three suppliers are listed for this compound. Additional details are available on the amantadine hydrochloride profile page.

Summary for 075819

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

Pharmacology for NDA: 075819

Mechanism of ActionM2 Protein Inhibitors

Medical Subject Heading (MeSH) Categories for 075819

Suppliers and Packaging for NDA: 075819

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMANTADINE HYDROCHLORIDE amantadine hydrochloride SYRUP;ORAL 075819 ANDA CMP Pharma, Inc. 46287-015 46287-015-01 473 mL in 1 BOTTLE (46287-015-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength50MG/5ML
Approval Date:Sep 11, 2002TE:AARLD:No


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Serving leading biopharmaceutical companies globally:

Dow
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Cantor Fitzgerald
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Harvard Business School
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Healthtrust
Daiichi Sankyo

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