Details for New Drug Application (NDA): 076242
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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 076242
Tradename: | CALCITRIOL |
Applicant: | Hikma |
Ingredient: | calcitriol |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 076242
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CALCITRIOL | calcitriol | SOLUTION;ORAL | 076242 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-3120 | 0054-3120-41 | 1 BOTTLE, GLASS in 1 CARTON (0054-3120-41) / 15 mL in 1 BOTTLE, GLASS |
CALCITRIOL | calcitriol | SOLUTION;ORAL | 076242 | ANDA | ATLANTIC BIOLOGICALS CORP. | 17856-3120 | 17856-3120-1 | 120 SYRINGE in 1 BOX, UNIT-DOSE (17856-3120-1) / .5 mL in 1 SYRINGE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 1MCG/ML | ||||
Approval Date: | Jul 18, 2003 | TE: | AA | RLD: | No |
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