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Details for New Drug Application (NDA): 091182

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NDA 091182 describes GLYCOPYRROLATE, which is a drug marketed by Watson Labs, Natco Pharma Ltd, Vintage Pharms, Rising Pharms Inc, Nexgen Pharma, Luitpold, Hikma Intl Pharms, Sun Pharm Inds Ltd, Dr Reddys Labs Ltd, Par Pharm, Hikma Farmaceutica, Corepharma, Teva Parenteral, Abraxis Pharm, Aurolife Pharma Llc, Stason Pharms, Hospira, and Leading Pharma Llc, and is included in twenty-three NDAs. It is available from twenty-four suppliers. Additional details are available on the GLYCOPYRROLATE profile page.

The generic ingredient in GLYCOPYRROLATE is glycopyrrolate. There are fourteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.

Summary for NDA: 091182

Stason Pharms
Therapeutic Class:Gastrointestinal Agents

Pharmacology for NDA: 091182

Mechanism of ActionCholinergic Antagonists

Suppliers and Packaging for NDA: 091182

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 091182 ANDA Golden State Medical Supply, Inc. 60429-665 60429-665-01 100 TABLET in 1 BOTTLE (60429-665-01)
TABLET;ORAL 091182 ANDA Golden State Medical Supply, Inc. 60429-666 60429-666-01 100 TABLET in 1 BOTTLE (60429-666-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Feb 3, 2014TE:AARLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Feb 3, 2014TE:AARLD:No
Regulatory Exclusivity Expiration:Jun 18, 2016
Regulatory Exclusivity Use:PATENT CHALLENGE

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