Details for New Drug Application (NDA): 090963
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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 090963
Tradename: | GLYCOPYRROLATE |
Applicant: | Hikma Farmaceutica |
Ingredient: | glycopyrrolate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 090963
Mechanism of Action | Cholinergic Antagonists Cholinergic Muscarinic Antagonists |
Medical Subject Heading (MeSH) Categories for 090963
Suppliers and Packaging for NDA: 090963
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GLYCOPYRROLATE | glycopyrrolate | INJECTABLE;INJECTION | 090963 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9584 | 0143-9584-10 | 10 VIAL, MULTI-DOSE in 1 CARTON (0143-9584-10) / 20 mL in 1 VIAL, MULTI-DOSE (0143-9584-01) |
GLYCOPYRROLATE | glycopyrrolate | INJECTABLE;INJECTION | 090963 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9585 | 0143-9585-25 | 25 VIAL, MULTI-DOSE in 1 CARTON (0143-9585-25) / 5 mL in 1 VIAL, MULTI-DOSE (0143-9585-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.2MG/ML | ||||
Approval Date: | Sep 21, 2011 | TE: | AP | RLD: | No |
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