Details for New Drug Application (NDA): 207174
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NDA 207174 describes PARICALCITOL, which is a drug marketed by Amneal Pharms, Aurobindo Pharma Ltd, Bionpharma, Dr Reddys, Lotus Pharm Co Ltd, Marksans Pharma, Rising, Teva Pharms Usa, Accord Hlthcare, Amneal Pharms Co, Epic Pharma Llc, Eugia Pharma, Hikma Pharms, Hospira, and Sandoz, and is included in seventeen NDAs. It is available from eleven suppliers. Additional details are available on the PARICALCITOL profile page.
The generic ingredient in PARICALCITOL is paricalcitol. There are ten drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the paricalcitol profile page.
The generic ingredient in PARICALCITOL is paricalcitol. There are ten drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the paricalcitol profile page.
Summary for 207174
| Tradename: | PARICALCITOL |
| Applicant: | Accord Hlthcare |
| Ingredient: | paricalcitol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 207174
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PARICALCITOL | paricalcitol | SOLUTION;INTRAVENOUS | 207174 | NDA | Accord Healthcare, Inc. | 16729-310 | 16729-310-08 | 25 VIAL, SINGLE-DOSE in 1 CARTON (16729-310-08) / 1 mL in 1 VIAL, SINGLE-DOSE |
| PARICALCITOL | paricalcitol | SOLUTION;INTRAVENOUS | 207174 | NDA | Accord Healthcare, Inc. | 16729-310 | 16729-310-63 | 1 VIAL, SINGLE-DOSE in 1 CARTON (16729-310-63) / 1 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 0.002MG/ML (0.002MG/ML) | ||||
| Approval Date: | Feb 4, 2016 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 0.005MG/ML (0.005MG/ML) | ||||
| Approval Date: | Feb 4, 2016 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 0.01MG/2ML (0.005MG/ML) | ||||
| Approval Date: | Feb 4, 2016 | TE: | AP | RLD: | No | ||||
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