Details for New Drug Application (NDA): 212227
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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 212227
Tradename: | GLYCOPYRROLATE |
Applicant: | Xiromed |
Ingredient: | glycopyrrolate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 212227
Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for 212227
Suppliers and Packaging for NDA: 212227
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GLYCOPYRROLATE | glycopyrrolate | INJECTABLE;INJECTION | 212227 | ANDA | XIROMED LLC | 70700-264 | 70700-264-22 | 1 VIAL in 1 CARTON (70700-264-22) / 1 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.2MG/ML | ||||
Approval Date: | Mar 4, 2021 | TE: | AP | RLD: | No |
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