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Generated: November 14, 2018

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Details for New Drug Application (NDA): 210997

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NDA 210997 describes GLYRX-PF, which is a drug marketed by Exela Pharma Scs Llc and is included in one NDA. It is available from one supplier. Additional details are available on the GLYRX-PF profile page.

The generic ingredient in GLYRX-PF is glycopyrrolate. There are seventeen drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.
Summary for 210997
Tradename:GLYRX-PF
Applicant:Exela Pharma Scs Llc
Ingredient:glycopyrrolate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 210997
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for 210997
Suppliers and Packaging for NDA: 210997
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLYRX-PF glycopyrrolate SOLUTION;INTRAMUSCULAR, INTRAVENOUS 210997 NDA Exela Pharma Sciences, LLC 51754-6000 51754-6000-4 25 VIAL, SINGLE-DOSE in 1 CARTON (51754-6000-4) > 1 mL in 1 VIAL, SINGLE-DOSE
GLYRX-PF glycopyrrolate SOLUTION;INTRAMUSCULAR, INTRAVENOUS 210997 NDA Exela Pharma Sciences, LLC 51754-6001 51754-6001-4 25 VIAL, SINGLE-DOSE in 1 CARTON (51754-6001-4) > 2 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAMUSCULAR, INTRAVENOUSStrength0.2MG/ML (0.2MG/ML)
Approval Date:Jul 11, 2018TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAMUSCULAR, INTRAVENOUSStrength0.4MG/2ML (0.2MG/ML)
Approval Date:Jul 11, 2018TE:RLD:No

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