Details for New Drug Application (NDA): 212612
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NDA 212612 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 212612
| Tradename: | GLYCOPYRROLATE |
| Applicant: | Gland Pharma Ltd |
| Ingredient: | glycopyrrolate |
| Patents: | 0 |
Pharmacology for NDA: 212612
| Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for 212612
Suppliers and Packaging for NDA: 212612
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GLYCOPYRROLATE | glycopyrrolate | INJECTABLE;INJECTION | 212612 | ANDA | Gland Pharma Limited | 68083-376 | 68083-376-25 | 25 VIAL in 1 CARTON (68083-376-25) / 1 mL in 1 VIAL (68083-376-01) |
| GLYCOPYRROLATE | glycopyrrolate | INJECTABLE;INJECTION | 212612 | ANDA | Gland Pharma Limited | 68083-377 | 68083-377-25 | 25 VIAL in 1 CARTON (68083-377-25) / 2 mL in 1 VIAL (68083-377-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.2MG/ML | ||||
| Approval Date: | Sep 30, 2019 | TE: | AP | RLD: | No | ||||
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