Details for New Drug Application (NDA): 211939
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NDA 211939 describes BONSITY, which is a drug marketed by Alvogen and is included in one NDA. It is available from two suppliers. Additional details are available on the BONSITY profile page.
The generic ingredient in BONSITY is teriparatide. There is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the teriparatide profile page.
The generic ingredient in BONSITY is teriparatide. There is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the teriparatide profile page.
Summary for 211939
| Tradename: | BONSITY |
| Applicant: | Alvogen |
| Ingredient: | teriparatide |
| Patents: | 0 |
Suppliers and Packaging for NDA: 211939
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BONSITY | teriparatide | SOLUTION;SUBCUTANEOUS | 211939 | NDA | Alvogen, Inc. | 47781-652 | 47781-652-89 | 1 SYRINGE in 1 CARTON (47781-652-89) / 2.24 mL in 1 SYRINGE |
| BONSITY | teriparatide | SOLUTION;SUBCUTANEOUS | 211939 | NDA | Alvogen Inc. | 47781-852 | 47781-852-89 | 1 SYRINGE in 1 CARTON (47781-852-89) / 2.24 mL in 1 SYRINGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | 0.56MG/2.24ML (0.25MG/ML) | ||||
| Approval Date: | Oct 4, 2019 | TE: | RLD: | No | |||||
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