Details for New Drug Application (NDA): 214213
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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 214213
Tradename: | GLYCOPYRROLATE |
Applicant: | Zydus Pharms |
Ingredient: | glycopyrrolate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 214213
Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for 214213
Suppliers and Packaging for NDA: 214213
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GLYCOPYRROLATE | glycopyrrolate | INJECTABLE;INJECTION | 214213 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1645 | 70710-1645-7 | 25 VIAL in 1 CARTON (70710-1645-7) / 1 mL in 1 VIAL (70710-1645-1) |
GLYCOPYRROLATE | glycopyrrolate | INJECTABLE;INJECTION | 214213 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1646 | 70710-1646-7 | 25 VIAL in 1 CARTON (70710-1646-7) / 2 mL in 1 VIAL (70710-1646-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 0.2MG/ML | ||||
Approval Date: | Nov 9, 2021 | TE: | RLD: | No |
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