Details for New Drug Application (NDA): 203289
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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 203289
Tradename: | CALCITRIOL |
Applicant: | Amneal Pharms |
Ingredient: | calcitriol |
Patents: | 0 |
Suppliers and Packaging for NDA: 203289
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CALCITRIOL | calcitriol | CAPSULE;ORAL | 203289 | ANDA | Amneal Pharmaceuticals LLC | 65162-519 | 65162-519-03 | 30 CAPSULE in 1 BOTTLE (65162-519-03) |
CALCITRIOL | calcitriol | CAPSULE;ORAL | 203289 | ANDA | Amneal Pharmaceuticals LLC | 65162-519 | 65162-519-10 | 100 CAPSULE in 1 BOTTLE (65162-519-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.5MCG | ||||
Approval Date: | Jun 14, 2017 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.25MCG | ||||
Approval Date: | Jun 14, 2017 | TE: | AB | RLD: | No |
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