Details for New Drug Application (NDA): 076979
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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 |
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 | 49884-161-11 | 3.7 mL in 1 BOTTLE, GLASS (49884-161-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SPRAY, METERED;NASAL | Strength | 200 IU/SPRAY | ||||
Approval Date: | Jun 8, 2009 | TE: | RLD: | No |
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