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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040821

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NDA 040821 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-eight 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-five suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.

Summary for 040821

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

Pharmacology for NDA: 040821

Mechanism of ActionCholinergic Antagonists

Medical Subject Heading (MeSH) Categories for 040821

Suppliers and Packaging for NDA: 040821

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 040821 ANDA Mylan Institutional Inc. 51079-700 51079-700-20 100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-700-20) > 1 TABLET in 1 BLISTER PACK (51079-700-01)
GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 040821 ANDA Cardinal Health 55154-4393 55154-4393-0 10 BLISTER PACK in 1 BAG (55154-4393-0) > 1 TABLET in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Dec 29, 2008TE:AARLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Dec 29, 2008TE:AARLD:No


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