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, Onesource Specialty, Sun Pharm, Teva, Am Regent, Fresenius Kabi Usa, Fresenius Medcl, Gland, Hospira, Long Grove Pharms, Rockwell Medcl, Sagent Pharms, Teva Parenteral, Anda Repository, and Rising, and is included in eighteen NDAs. It is available from twenty 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-four 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-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 |
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 | A-S Medication Solutions | 50090-6711 | 50090-6711-0 | 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (50090-6711-0) |
| CALCITRIOL | calcitriol | CAPSULE;ORAL | 091174 | ANDA | Golden State Medical Supply, Inc. | 51407-169 | 51407-169-01 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (51407-169-01) |
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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