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Serving leading biopharmaceutical companies globally:

Cipla
Deloitte
Covington
Healthtrust
Daiichi Sankyo
Queensland Health
Dow
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Moodys
Fish and Richardson

Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075060

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NDA 075060 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 075060

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

Pharmacology for NDA: 075060

Mechanism of ActionM2 Protein Inhibitors

Medical Subject Heading (MeSH) Categories for 075060

Suppliers and Packaging for NDA: 075060

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMANTADINE HYDROCHLORIDE amantadine hydrochloride SYRUP;ORAL 075060 ANDA Atlantic Biologicals Corps 17856-0093 17856-0093-3 5 mL in 1 CUP, UNIT-DOSE (17856-0093-3)
AMANTADINE HYDROCHLORIDE amantadine hydrochloride SYRUP;ORAL 075060 ANDA Physicians Total Care, Inc. 54868-3216 54868-3216-0 473 mL in 1 BOTTLE (54868-3216-0)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength50MG/5ML
Approval Date:Dec 24, 1998TE:AARLD:No


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Serving leading biopharmaceutical companies globally:

McKesson
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Citi
Fish and Richardson
Novartis
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Chinese Patent Office
Mallinckrodt
Julphar
Deloitte

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