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Details for New Drug Application (NDA): 076979
NDA 076979 describes CALCITONIN-SALMON, which is a drug marketed by Igi Labs Inc, Apotex Inc, and Par Pharm, and is included in three NDAs. It is available from three 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 076979
| Tradename: | CALCITONIN-SALMON |
| Applicant: | Par Pharm |
| Ingredient: | calcitonin salmon |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 076979
| Ingredient-type | Calcitonin |
Suppliers and Packaging for NDA: 076979
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CALCITONIN-SALMON | calcitonin salmon | SPRAY, METERED;NASAL | 076979 | ANDA | Par Pharmaceutical, Inc. | 49884-161 | N | 49884-161-11 |
| CALCITONIN-SALMON | calcitonin salmon | SPRAY, METERED;NASAL | 076979 | ANDA | Physicians Total Care, Inc. | 54868-6323 | E | 54868-6323-0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY, METERED;NASAL | Strength | 200 IU/SPRAY | ||||
| Approval Date: | Jun 8, 2009 | TE: | AB | RLD: | No | ||||
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