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Generated: September 22, 2018

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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, Hikma Intl Pharms, Leading Pharma Llc, Natco Pharma Ltd, Nexgen Pharma, Oxford Pharms, Par Pharm, Renata, Rising Pharms, Santos Biotech, and Sun Pharm Inds Ltd, and is included in twenty-seven NDAs. It is available from thirty-one 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-nine suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.
Summary for 090963
Tradename:GLYCOPYRROLATE
Applicant:Hikma Farmaceutica
Ingredient:glycopyrrolate
Patents:0
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 Pharmaceuticals 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 Pharmaceuticals 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)

Profile for product number 001

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

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