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Details for New Drug Application (NDA): 091356
NDA 091356 describes CALCITRIOL, which is a drug marketed by Amneal Pharms, Bionpharma Inc, Strides Pharma, Teva, West-ward Pharms Int, Akorn, Fresenius Kabi Usa, Fresenius Medcl, Hospira, Luitpold, Rockwell Medcl, Sagent Pharms, and Teva Parenteral, and is included in fourteen NDAs. It is available from fifteen 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: | Strides Pharma |
| Ingredient: | calcitriol |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 091356
| Ingredient-type | Cholecalciferol |
Medical Subject Heading (MeSH) Categories for 091356
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 | Atlantic Biologicals Corps | 17856-0723 | 17856-0723-1 | 100 DOSE PACK in 1 CONTAINER (17856-0723-1) > 1 CAPSULE in 1 DOSE PACK |
| CALCITRIOL | calcitriol | CAPSULE;ORAL | 091356 | ANDA | Heritage Pharmaceuticals Inc. | 23155-662 | 23155-662-01 | 100 CAPSULE in 1 BOTTLE (23155-662-01) |
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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