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Details for New Drug Application (NDA): 040821

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NDA 040821 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: 040821

Tradename:
GLYCOPYRROLATE
Applicant:
Rising Pharms Inc
Ingredient:
glycopyrrolate
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 040821

Mechanism of ActionCholinergic Antagonists

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 Qualitest Pharmaceuticals 0603-3180 0603-3180-10 10 TABLET in 1 BOTTLE, PLASTIC (0603-3180-10)
GLYCOPYRROLATE
glycopyrrolate
TABLET;ORAL 040821 ANDA Qualitest Pharmaceuticals 0603-3180 0603-3180-21 100 TABLET in 1 BOTTLE, PLASTIC (0603-3180-21)

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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