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Generated: April 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090195

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NDA 090195 describes GLYCOPYRROLATE, which is a drug marketed by Abraxis Pharm, Amneal Pharms Co, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Luitpold, Somerset Theraps Llc, Teva Parenteral, Watson Labs, Appco Pharma Llc, Aurolife Pharma Llc, Dr Reddys Labs Ltd, Epic Pharma Llc, Hikma Intl Pharms, Leading Pharma Llc, Natco Pharma Ltd, Nexgen Pharma, Par Pharm, Rising Pharms Inc, Santos Biotech, Sun Pharm Inds Ltd, and Vintage Pharms, and is included in twenty-seven NDAs. It is available from twenty-nine suppliers. Additional details are available on the GLYCOPYRROLATE profile page.

The generic ingredient in GLYCOPYRROLATE is glycopyrrolate. There are seventeen drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.
Summary for 090195
Tradename:GLYCOPYRROLATE
Applicant:Leading Pharma Llc
Ingredient:glycopyrrolate
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090195
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for 090195
Suppliers and Packaging for NDA: 090195
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 090195 ANDA Major Pharmaceuticals 0904-6521 N 0904-6521-61
GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 090195 ANDA AvKARE, Inc. 42291-303 N 42291-303-90

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Sep 21, 2012TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Sep 21, 2012TE:AARLD:No

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