DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 091356
The generic ingredient in CALCITRIOL is calcitriol. There are ten drug master file entries for this compound. Twenty-one 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 | N | 17856-0723-1 |
CALCITRIOL | calcitriol | CAPSULE;ORAL | 091356 | ANDA | Bryant Ranch Prepack | 63629-7311 | N | 63629-7311-1 |
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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