Details for New Drug Application (NDA): 091356
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NDA 091356 describes CALCITRIOL, which is a drug marketed by Amneal Pharms, Bionpharma, Hikma, Humanwell Puracap, 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 nineteen 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-two 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-two suppliers are listed for this compound. Additional details are available on the calcitriol profile page.
Summary for 091356
| Tradename: | CALCITRIOL |
| Applicant: | Onesource Specialty |
| Ingredient: | calcitriol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 091356
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CALCITRIOL | calcitriol | CAPSULE;ORAL | 091356 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-662 | 23155-662-01 | 100 CAPSULE in 1 BOTTLE (23155-662-01) |
| CALCITRIOL | calcitriol | CAPSULE;ORAL | 091356 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-662 | 23155-662-03 | 30 CAPSULE in 1 BOTTLE (23155-662-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.25MCG | ||||
| Approval Date: | Dec 12, 2014 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.5MCG | ||||
| Approval Date: | Dec 12, 2014 | TE: | AB | RLD: | No | ||||
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