Details for New Drug Application (NDA): 212802
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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 212802
Tradename: | GLYCOPYRROLATE |
Applicant: | Meitheal |
Ingredient: | glycopyrrolate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 212802
Mechanism of Action | Cholinergic Antagonists Cholinergic Muscarinic Antagonists |
Medical Subject Heading (MeSH) Categories for 212802
Suppliers and Packaging for NDA: 212802
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GLYCOPYRROLATE | glycopyrrolate | INJECTABLE;INJECTION | 212802 | ANDA | Meitheal Pharmaceuticals Inc. | 71288-414 | 71288-414-92 | 25 VIAL, SINGLE-DOSE in 1 CARTON (71288-414-92) / 1 mL in 1 VIAL, SINGLE-DOSE (71288-414-91) |
GLYCOPYRROLATE | glycopyrrolate | INJECTABLE;INJECTION | 212802 | ANDA | Meitheal Pharmaceuticals Inc. | 71288-414 | 71288-414-94 | 25 VIAL, SINGLE-DOSE in 1 CARTON (71288-414-94) / 2 mL in 1 VIAL, SINGLE-DOSE (71288-414-93) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.2MG/ML | ||||
Approval Date: | Jul 6, 2021 | TE: | AP | RLD: | No |
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