Details for New Drug Application (NDA): 091522
✉ Email this page to a colleague
The generic ingredient in GLYCOPYRROLATE is glycopyrrolate. There are seventeen drug master file entries for this compound. Fifty-seven suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.
Summary for 091522
Tradename: | GLYCOPYRROLATE |
Applicant: | Lgm Pharma |
Ingredient: | glycopyrrolate |
Patents: | 0 |
Pharmacology for NDA: 091522
Mechanism of Action | Cholinergic Antagonists Cholinergic Muscarinic Antagonists |
Medical Subject Heading (MeSH) Categories for 091522
Suppliers and Packaging for NDA: 091522
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GLYCOPYRROLATE | glycopyrrolate | TABLET;ORAL | 091522 | ANDA | FH2 Pharma LLC | 72887-160 | 72887-160-03 | 30 TABLET in 1 BOTTLE (72887-160-03) |
GLYCOPYRROLATE | glycopyrrolate | TABLET;ORAL | 091522 | ANDA | LGM PHARMA SOLUTIONS, LLC | 79739-7097 | 79739-7097-1 | 100 TABLET in 1 BOTTLE, PLASTIC (79739-7097-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1.5MG | ||||
Approval Date: | Mar 12, 2012 | TE: | RLD: | No |
Complete Access Available with Subscription