Details for New Drug Application (NDA): 213238
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The generic ingredient in GLYCOPYRROLATE is glycopyrrolate. There are seventeen drug master file entries for this compound. Fifty-six suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.
Summary for 213238
Tradename: | GLYCOPYRROLATE |
Applicant: | Accord Hlthcare |
Ingredient: | glycopyrrolate |
Patents: | 0 |
Pharmacology for NDA: 213238
Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for 213238
Suppliers and Packaging for NDA: 213238
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GLYCOPYRROLATE | glycopyrrolate | INJECTABLE;INJECTION | 213238 | ANDA | Accord Healthcare, Inc., | 16729-471 | 16729-471-08 | 25 VIAL, SINGLE-DOSE in 1 CARTON (16729-471-08) / 1 mL in 1 VIAL, SINGLE-DOSE |
GLYCOPYRROLATE | glycopyrrolate | INJECTABLE;INJECTION | 213238 | ANDA | Accord Healthcare, Inc., | 16729-472 | 16729-472-08 | 25 VIAL, SINGLE-DOSE in 1 CARTON (16729-472-08) / 2 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.2MG/ML | ||||
Approval Date: | Jul 8, 2020 | TE: | AP | RLD: | No |
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