Details for New Drug Application (NDA): 212416
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NDA 212416 describes CALCITONIN-SALMON, which is a drug marketed by Cipla, Custopharm Inc, Dr Reddys, Endo Operations, Igi Labs Inc, and Apotex Inc, and is included in seven NDAs. It is available from six suppliers. Additional details are available on the CALCITONIN-SALMON profile page.
The generic ingredient in CALCITONIN-SALMON is calcitonin salmon. There are fourteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the calcitonin salmon profile page.
The generic ingredient in CALCITONIN-SALMON is calcitonin salmon. There are fourteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the calcitonin salmon profile page.
Summary for 212416
| Tradename: | CALCITONIN-SALMON |
| Applicant: | Custopharm Inc |
| Ingredient: | calcitonin salmon |
| Patents: | 0 |
Suppliers and Packaging for NDA: 212416
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CALCITONIN-SALMON | calcitonin salmon | INJECTABLE;INJECTION | 212416 | ANDA | Hikma Pharmaceuticals USA Inc.(dba Leucadia Pharmaceuticals) | 24201-400 | 24201-400-02 | 1 VIAL, MULTI-DOSE in 1 CARTON (24201-400-02) / 2 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 200 IU/ML | ||||
| Approval Date: | May 14, 2021 | TE: | AP | RLD: | No | ||||
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