Details for New Drug Application (NDA): 206699
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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 206699
Tradename: | PARICALCITOL |
Applicant: | Amneal Pharms Co |
Ingredient: | paricalcitol |
Patents: | 0 |
Suppliers and Packaging for NDA: 206699
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PARICALCITOL | paricalcitol | SOLUTION;INTRAVENOUS | 206699 | ANDA | Amneal Pharmaceuticals LLC | 70121-1033 | 70121-1033-5 | 25 VIAL, SINGLE-DOSE in 1 CARTON (70121-1033-5) / 1 mL in 1 VIAL, SINGLE-DOSE (70121-1033-1) |
PARICALCITOL | paricalcitol | SOLUTION;INTRAVENOUS | 206699 | ANDA | Amneal Pharmaceuticals LLC | 70121-1033 | 70121-1033-7 | 10 VIAL, SINGLE-DOSE in 1 CARTON (70121-1033-7) / 1 mL in 1 VIAL, SINGLE-DOSE (70121-1033-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 0.002MG/ML (0.002MG/ML) | ||||
Approval Date: | Mar 9, 2017 | 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: | Mar 9, 2017 | 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: | Mar 9, 2017 | TE: | AP | RLD: | No |
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