Details for New Drug Application (NDA): 202675
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NDA 202675 describes GLYCOPYRROLATE, which is a drug marketed by Abraxis Pharm, Accord Hlthcare, Alembic, Am Regent, Amneal, Apotex, Aspen, Caplin, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira, Lupin Ltd, Mankind Pharma, Meitheal, Nivagen Pharms Inc, Piramal Critical, Prinston Inc, Sagent, Sandoz, Somerset Theraps Llc, Teva Parenteral, Watson Labs, Xiromed, Zydus Pharms, Annora Pharma, Par Pharm Inc, Suven Pharms, Aurobindo Pharma, Chartwell Rx, Dr Reddys Labs Ltd, Heritage Pharms Inc, Hikma Intl Pharms, Indoco, Leading, Lgm Pharma, Natco, Oxford Pharms, Par Pharm, Rising, and Sun Pharm Inds Ltd, and is included in fifty-one NDAs. It is available from forty-eight 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-five 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-five suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.
Summary for 202675
| Tradename: | GLYCOPYRROLATE |
| Applicant: | Aurobindo Pharma |
| Ingredient: | glycopyrrolate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 202675
| Mechanism of Action | Cholinergic Antagonists Cholinergic Muscarinic Antagonists |
Medical Subject Heading (MeSH) Categories for 202675
Suppliers and Packaging for NDA: 202675
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GLYCOPYRROLATE | glycopyrrolate | TABLET;ORAL | 202675 | ANDA | Aurolife Pharma LLC | 13107-014 | 13107-014-01 | 100 TABLET in 1 BOTTLE (13107-014-01) |
| GLYCOPYRROLATE | glycopyrrolate | TABLET;ORAL | 202675 | ANDA | Aurolife Pharma LLC | 13107-015 | 13107-015-01 | 100 TABLET in 1 BOTTLE (13107-015-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Apr 15, 2013 | TE: | AA | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Oct 30, 2018 | TE: | AA | RLD: | No | ||||
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