Details for New Drug Application (NDA): 091174
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NDA 091174 describes CALCITRIOL, which is a drug marketed by Amneal Pharms, Bionpharma, Hikma, Strides Pharma, Sun Pharm, Teva, Am Regent, Fresenius Kabi Usa, Fresenius Medcl, Gland Pharma Ltd, Hospira, Long Grove Pharms, Rockwell Medcl, Sagent Pharms, Teva Parenteral, Patrin, and Rising, and is included in eighteen NDAs. It is available from nineteen suppliers. Additional details are available on the CALCITRIOL profile page.
The generic ingredient in CALCITRIOL is calcitriol. There are ten drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the calcitriol profile page.
The generic ingredient in CALCITRIOL is calcitriol. There are ten drug master file entries for this compound. Twenty-three 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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