Details for New Drug Application (NDA): 204438
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NDA 204438 describes GLYCOPYRROLATE, which is a drug marketed by Abraxis Pharm, Accord Hlthcare, Alembic, Am Regent, Amneal, Apotex, Caplin, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira, Lupin Ltd, Mankind Pharma, Meitheal, Omnivium Pharms, Piramal Critical, Prinston Inc, Sagent, Sandoz, Somerset Theraps Llc, Teva Parenteral, Umedica, Watson Labs, Xiromed, Zydus Pharms, Annora Pharma, Chartwell Rx, Endo Operations, Granules, Saptalis Pharms, Suven Pharms, Adaptis, Aurobindo Pharma, Dr Reddys Labs Ltd, Heritage Pharms Inc, Hikma Intl Pharms, Lgm Pharma, Natco, Oxford Pharms, Quagen, Rising, Sun Pharm Inds Ltd, and Velzen Pharma Pvt, and is included in fifty-five NDAs. It is available from fifty suppliers. Additional details are available on the GLYCOPYRROLATE profile page.
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.
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 204438
| Tradename: | GLYCOPYRROLATE |
| Applicant: | Endo Operations |
| Ingredient: | glycopyrrolate |
| Patents: | 0 |
Pharmacology for NDA: 204438
| Mechanism of Action | Cholinergic Antagonists Cholinergic Muscarinic Antagonists |
Medical Subject Heading (MeSH) Categories for 204438
Suppliers and Packaging for NDA: 204438
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GLYCOPYRROLATE | glycopyrrolate | SOLUTION;ORAL | 204438 | ANDA | Endo USA, Inc. | 49884-042 | 49884-042-33 | 16 mL in 1 BOTTLE (49884-042-33) |
| GLYCOPYRROLATE | glycopyrrolate | SOLUTION;ORAL | 204438 | ANDA | Bryant Ranch Prepack | 63629-9592 | 63629-9592-1 | 473 mL in 1 BOTTLE (63629-9592-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 1MG/5ML | ||||
| Approval Date: | Aug 9, 2021 | TE: | AA | RLD: | No | ||||
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