Details for New Drug Application (NDA): 215715
NDA 215715 describes CALCITONIN-SALMON, which is a drug marketed by Amneal, Cipla, Custopharm Inc, Dr Reddys, Fresenius Kabi Usa, Igi Labs Inc, Ph Health, Sagent, Zydus Pharms, and Apotex Inc, and is included in eleven NDAs. It is available from ten suppliers. Additional details are available on the CALCITONIN-SALMON profile page.
The generic ingredient in CALCITONIN-SALMON is calcitonin salmon. There is one drug master file entry for this compound. Eleven 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 is one drug master file entry for this compound. Eleven suppliers are listed for this compound. Additional details are available on the calcitonin salmon profile page.
Summary for 215715
| Tradename: | CALCITONIN-SALMON |
| Applicant: | Dr Reddys |
| Ingredient: | calcitonin salmon |
| Patents: | 0 |
Suppliers and Packaging for NDA: 215715
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CALCITONIN-SALMON | calcitonin salmon | INJECTABLE;INJECTION | 215715 | ANDA | Dr. Reddy's Laboratories, Inc. | 43598-051 | 43598-051-11 | 1 VIAL, MULTI-DOSE in 1 CARTON (43598-051-11) / 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: | Apr 11, 2024 | TE: | AP | RLD: | No | ||||
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