Details for New Drug Application (NDA): 089335
✉ Email this page to a colleague
The generic ingredient in GLYCOPYRROLATE 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 089335
Tradename: | GLYCOPYRROLATE |
Applicant: | Am Regent |
Ingredient: | glycopyrrolate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 089335
Mechanism of Action | Cholinergic Antagonists Cholinergic Muscarinic Antagonists |
Medical Subject Heading (MeSH) Categories for 089335
Suppliers and Packaging for NDA: 089335
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GLYCOPYRROLATE | glycopyrrolate | INJECTABLE;INJECTION | 089335 | ANDA | American Regent, Inc. | 0517-4601 | 0517-4601-25 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-4601-25) / 1 mL in 1 VIAL, SINGLE-DOSE |
GLYCOPYRROLATE | glycopyrrolate | INJECTABLE;INJECTION | 089335 | ANDA | American Regent, Inc. | 0517-4602 | 0517-4602-25 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-4602-25) / 2 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.2MG/ML | ||||
Approval Date: | Jul 23, 1986 | TE: | AP | RLD: | No |
Complete Access Available with Subscription