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Serving leading biopharmaceutical companies globally:

Covington
Medtronic
McKesson
Mallinckrodt
US Army
Express Scripts
US Department of Justice
Fuji
UBS
Argus Health

Generated: October 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090963

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NDA 090963 describes GLYCOPYRROLATE, which is a drug marketed by Watson Labs, Appco Pharma Llc, Natco Pharma Ltd, Vintage Pharms, Rising Pharms Inc, Nexgen Pharma, Luitpold, Hikma Intl Pharms, Somerset Theraps Llc, Sun Pharm Inds Ltd, Dr Reddys Labs Ltd, Par Pharm, Hikma Farmaceutica, Epic Pharma Llc, Teva Parenteral, Amneal Pharms Co, Abraxis Pharm, Aurolife Pharma Llc, Santos Biotech, Hospira, and Leading Pharma Llc, and is included in twenty-six NDAs. It is available from twenty-seven 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-two suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.

Summary for NDA: 090963

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

Pharmacology for NDA: 090963

Mechanism of ActionCholinergic Antagonists

Suppliers and Packaging for NDA: 090963

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLYCOPYRROLATE
glycopyrrolate
INJECTABLE;INJECTION 090963 ANDA West-Ward Pharmaceutical Corp 0143-9584 0143-9584-10 10 VIAL, MULTI-DOSE in 1 CARTON (0143-9584-10) > 20 mL in 1 VIAL, MULTI-DOSE (0143-9584-01)
GLYCOPYRROLATE
glycopyrrolate
INJECTABLE;INJECTION 090963 ANDA West-Ward Pharmaceutical Corp 0143-9585 0143-9585-25 25 VIAL, MULTI-DOSE in 1 CARTON (0143-9585-25) > 5 mL in 1 VIAL, MULTI-DOSE (0143-9585-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.2MG/ML
Approval Date:Sep 21, 2011TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

Baxter
Queensland Health
AstraZeneca
Julphar
Moodys
Accenture
Harvard Business School
Mallinckrodt
Farmers Insurance
Fish and Richardson

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