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Glycopyrrolate

glycopyrrolate

Approved
Approval ID

d93a9b2b-708d-4db5-8aae-45fd3a7ca65c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 4, 2023

Manufacturers
FDA

Bryant Ranch Prepack

DUNS: 171714327

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

glycopyrrolate

PRODUCT DETAILS

NDC Product Code72162-1477
Application NumberANDA040653
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 13, 2018
Generic Nameglycopyrrolate

INGREDIENTS (6)

GLYCOPYRROLATEActive
Quantity: 1 mg in 1 1
Code: V92SO9WP2I
Classification: ACTIB
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT

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Glycopyrrolate - FDA Drug Approval Details