Details for New Drug Application (NDA): 212411
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NDA 212411 describes POSACONAZOLE, which is a drug marketed by Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Mylan Labs Ltd, Par Sterile Products, Hikma, Actavis Labs Fl Inc, Aet Pharma, Amneal, Biocon Pharma, Dr Reddys, Hetero Labs Ltd Iii, I 3 Pharms, Sinotherapeutics Inc, Specgx Llc, and Westminster Pharms, and is included in sixteen NDAs. It is available from twenty-five 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-seven 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-seven suppliers are listed for this compound. Additional details are available on the posaconazole profile page.
Summary for 212411
| Tradename: | POSACONAZOLE |
| Applicant: | Sinotherapeutics Inc |
| Ingredient: | posaconazole |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 212411
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| POSACONAZOLE | posaconazole | TABLET, DELAYED RELEASE;ORAL | 212411 | ANDA | Lannett Company Inc. | 0527-2133 | 0527-2133-30 | 24 TABLET, DELAYED RELEASE in 1 CARTON (0527-2133-30) |
| POSACONAZOLE | posaconazole | TABLET, DELAYED RELEASE;ORAL | 212411 | ANDA | Lannett Company Inc. | 0527-2133 | 0527-2133-35 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (0527-2133-35) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 100MG | ||||
| Approval Date: | Aug 21, 2019 | TE: | AB | RLD: | No | ||||
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