Details for New Drug Application (NDA): 210997

NDA 210997 describes GLYRX-PF, which is a drug marketed by Exela Pharma 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. Fifty-five suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.

Summary for 210997

Tradename:	GLYRX-PF
Applicant:	Exela Pharma
Ingredient:	glycopyrrolate
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 210997

Mechanism of Action

Cholinergic Antagonists

Medical Subject Heading (MeSH) Categories for 210997

Adjuvants, Anesthesia

Muscarinic Antagonists

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:	RX	Dosage:	SOLUTION;INTRAMUSCULAR, INTRAVENOUS			Strength	0.2MG/ML (0.2MG/ML)
Approval Date:	Jul 11, 2018	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAMUSCULAR, INTRAVENOUS			Strength	0.4MG/2ML (0.2MG/ML)
Approval Date:	Jul 11, 2018	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAMUSCULAR, INTRAVENOUS			Strength	1MG/5ML (0.2MG/ML)
Approval Date:	Apr 9, 2020	TE:		RLD:	Yes

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