Details for New Drug Application (NDA): 211097
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NDA 211097 describes TERIPARATIDE, which is a drug marketed by Almaject, Apotex, and Teva Pharms Usa, and is included in three NDAs. It is available from two suppliers. Additional details are available on the TERIPARATIDE profile page.
The generic ingredient in TERIPARATIDE is teriparatide. There are four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the teriparatide profile page.
The generic ingredient in TERIPARATIDE is teriparatide. There are four drug master file entries for this compound. Five 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) / 2.4 mL in 1 SYRINGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | 0.6MG/2.4ML (0.25MG/ML) | ||||
| Approval Date: | Nov 16, 2023 | TE: | AP | RLD: | No | ||||
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