Details for New Drug Application (NDA): 207639
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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 207639
Tradename: | GLYCOPYRROLATE |
Applicant: | Somerset Theraps Llc |
Ingredient: | glycopyrrolate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 207639
Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for 207639
Suppliers and Packaging for NDA: 207639
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GLYCOPYRROLATE | glycopyrrolate | INJECTABLE;INJECTION | 207639 | ANDA | Somerset Therapeutics, LLC | 70069-616 | 70069-616-10 | 10 VIAL in 1 CARTON (70069-616-10) / 20 mL in 1 VIAL (70069-616-01) |
GLYCOPYRROLATE | glycopyrrolate | INJECTABLE;INJECTION | 207639 | ANDA | Medical Purchasing Solutions, LLC | 71872-7012 | 71872-7012-1 | 10 VIAL in 1 BAG (71872-7012-1) / 20 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.2MG/ML | ||||
Approval Date: | Jun 23, 2017 | TE: | AP | RLD: | No |
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