Details for New Drug Application (NDA): 211097
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NDA 211097 describes TERIPARATIDE, which is a drug marketed by Almaject, Amphastar Pharms Inc, Apotex, and Teva Pharms Usa, and is included in four NDAs. It is available from four suppliers. Additional details are available on the TERIPARATIDE profile page.
The generic ingredient in TERIPARATIDE 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 TERIPARATIDE 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 211097
| Tradename: | TERIPARATIDE |
| Applicant: | Apotex |
| Ingredient: | teriparatide |
| Patents: | 0 |
Suppliers and Packaging for NDA: 211097
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TERIPARATIDE | teriparatide | SOLUTION;SUBCUTANEOUS | 211097 | ANDA | Apotex Corp. | 60505-6188 | 60505-6188-0 | 1 SYRINGE in 1 CARTON (60505-6188-0) / 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: | Nov 16, 2023 | TE: | AP | RLD: | No | ||||
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