Details for New Drug Application (NDA): 213698
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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 213698
Tradename: | GLYCOPYRROLATE |
Applicant: | Annora Pharma |
Ingredient: | glycopyrrolate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 213698
Mechanism of Action | Cholinergic Antagonists Cholinergic Muscarinic Antagonists |
Medical Subject Heading (MeSH) Categories for 213698
Suppliers and Packaging for NDA: 213698
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GLYCOPYRROLATE | glycopyrrolate | SOLUTION;ORAL | 213698 | ANDA | Camber Pharmaceuticals, Inc. | 31722-016 | 31722-016-47 | 1 BOTTLE in 1 CARTON (31722-016-47) / 473 mL in 1 BOTTLE |
GLYCOPYRROLATE | glycopyrrolate | SOLUTION;ORAL | 213698 | ANDA | NorthStar RxLLC | 72603-240 | 72603-240-01 | 1 BOTTLE in 1 CARTON (72603-240-01) / 473 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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