Details for New Drug Application (NDA): 208569
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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 208569
Tradename: | TERIPARATIDE |
Applicant: | Teva Pharms Usa |
Ingredient: | teriparatide |
Patents: | 0 |
Suppliers and Packaging for NDA: 208569
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TERIPARATIDE | teriparatide | SOLUTION;SUBCUTANEOUS | 208569 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-1106 | 0093-1106-16 | 1 SYRINGE in 1 CARTON (0093-1106-16) / 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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