Details for New Drug Application (NDA): 091174
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The generic ingredient in CALCITRIOL is calcitriol. There are ten drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the calcitriol profile page.
Summary for 091174
Tradename: | CALCITRIOL |
Applicant: | Bionpharma |
Ingredient: | calcitriol |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 091174
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CALCITRIOL | calcitriol | CAPSULE;ORAL | 091174 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 43353-998 | 43353-998-09 | 9000 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (43353-998-09) |
CALCITRIOL | calcitriol | CAPSULE;ORAL | 091174 | ANDA | A-S Medication Solutions | 50090-6711 | 50090-6711-0 | 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (50090-6711-0) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.25MCG | ||||
Approval Date: | May 24, 2013 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.5MCG | ||||
Approval Date: | May 24, 2013 | TE: | AB | RLD: | No |
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