Details for New Drug Application (NDA): 212467
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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 212467
Tradename: | GLYCOPYRROLATE |
Applicant: | Suven Pharms |
Ingredient: | glycopyrrolate |
Patents: | 0 |
Pharmacology for NDA: 212467
Mechanism of Action | Cholinergic Antagonists Cholinergic Muscarinic Antagonists |
Medical Subject Heading (MeSH) Categories for 212467
Suppliers and Packaging for NDA: 212467
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GLYCOPYRROLATE | glycopyrrolate | SOLUTION;ORAL | 212467 | ANDA | Taro Pharmaceuticals U.S.A. Inc. | 51672-5316 | 51672-5316-9 | 1 BOTTLE in 1 CARTON (51672-5316-9) / 500 mL in 1 BOTTLE |
GLYCOPYRROLATE | glycopyrrolate | SOLUTION;ORAL | 212467 | ANDA | Suven Pharmaceuticals Limited | 68022-0156 | 68022-0156-1 | 1 BOTTLE in 1 CARTON (68022-0156-1) / 500 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 1MG/5ML | ||||
Approval Date: | Jul 5, 2022 | TE: | AA | RLD: | No |
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