Details for New Drug Application (NDA): 217553
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NDA 217553 describes POSACONAZOLE, which is a drug marketed by Endo Operations, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Mylan Labs Ltd, Hikma, Actavis Labs Fl Inc, Aet Pharma, Amneal, Aurobindo Pharma, Biocon Pharma, Dr Reddys, Hetero Labs Ltd Iii, I 3 Pharms, Sinotherapeutics Inc, Specgx Llc, and Westminster Pharms, and is included in seventeen NDAs. It is available from twenty-seven suppliers. Additional details are available on the POSACONAZOLE profile page.
The generic ingredient in POSACONAZOLE is posaconazole. There are twenty-one drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the posaconazole profile page.
The generic ingredient in POSACONAZOLE is posaconazole. There are twenty-one drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the posaconazole profile page.
Summary for 217553
| Tradename: | POSACONAZOLE |
| Applicant: | Gland Pharma Ltd |
| Ingredient: | posaconazole |
| Patents: | 0 |
Suppliers and Packaging for NDA: 217553
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| POSACONAZOLE | posaconazole | SOLUTION;INTRAVENOUS | 217553 | ANDA | Gland Pharma Limited | 68083-577 | 68083-577-01 | 1 VIAL in 1 CARTON (68083-577-01) / 16.7 mL in 1 VIAL |
| POSACONAZOLE | posaconazole | SOLUTION;INTRAVENOUS | 217553 | ANDA | GLENMARK PHARMACEUTICALS INC., USA | 68462-904 | 68462-904-01 | 1 VIAL in 1 CARTON (68462-904-01) / 16.7 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 300MG/16.7ML (18MG/ML) | ||||
| Approval Date: | Dec 26, 2023 | TE: | AP | RLD: | No | ||||
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