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US Department of Justice
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Generated: December 12, 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 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 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

Medical Subject Heading (MeSH) Categories for 090963

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:

Accenture
Express Scripts
Cerilliant
Daiichi Sankyo
Medtronic
Cantor Fitzgerald
Harvard Business School
Julphar
UBS
Chinese Patent Office

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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