Details for New Drug Application (NDA): 076396
✉ Email this page to a colleague
NDA 076396 describes CALCITONIN-SALMON, which is a drug marketed by Custopharm Inc, Igi Labs Inc, Par Sterile Products, Apotex Inc, and Par Pharm, and is included in five NDAs. It is available from four 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. Five 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. Five suppliers are listed for this compound. Additional details are available on the calcitonin salmon profile page.
Summary for 076396
| Tradename: | CALCITONIN-SALMON |
| Applicant: | Apotex Inc |
| Ingredient: | calcitonin salmon |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 076396
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CALCITONIN-SALMON | calcitonin salmon | SPRAY, METERED;NASAL | 076396 | ANDA | Apotex Corp. | 60505-0823 | 60505-0823-0 | 1 BOTTLE, GLASS in 1 CARTON (60505-0823-0) / 14 SPRAY, METERED in 1 BOTTLE, GLASS |
| CALCITONIN-SALMON | calcitonin salmon | SPRAY, METERED;NASAL | 076396 | ANDA | Apotex Corp. | 60505-0823 | 60505-0823-6 | 1 BOTTLE, GLASS in 1 CARTON (60505-0823-6) / 30 SPRAY, METERED in 1 BOTTLE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY, METERED;NASAL | Strength | 200 IU/SPRAY | ||||
| Approval Date: | Nov 17, 2008 | TE: | RLD: | No | |||||
Complete Access Available with Subscription
