Details for New Drug Application (NDA): 208973
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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 208973
Tradename: | GLYCOPYRROLATE |
Applicant: | Amneal |
Ingredient: | glycopyrrolate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 208973
Mechanism of Action | Cholinergic Antagonists Cholinergic Muscarinic Antagonists |
Medical Subject Heading (MeSH) Categories for 208973
Suppliers and Packaging for NDA: 208973
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GLYCOPYRROLATE | glycopyrrolate | INJECTABLE;INJECTION | 208973 | ANDA | Henry Schein, Inc. | 0404-9870 | 0404-9870-05 | 1 VIAL in 1 BAG (0404-9870-05) / 5 mL in 1 VIAL |
GLYCOPYRROLATE | glycopyrrolate | INJECTABLE;INJECTION | 208973 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1425 | 51662-1425-1 | 1 mL in 1 VIAL (51662-1425-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.2MG/ML | ||||
Approval Date: | Jun 15, 2017 | TE: | AP | RLD: | No |
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