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Details for New Drug Application (NDA): 091433

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NDA 091433 describes DOXERCALCIFEROL, which is a drug marketed by Hikma Pharms Llc, Rising Pharms Inc, Sandoz Inc, Akorn Inc, and West-ward Pharms Int, and is included in six NDAs. It is available from five suppliers. Additional details are available on the DOXERCALCIFEROL profile page.

The generic ingredient in DOXERCALCIFEROL is doxercalciferol. There are nine drug master file entries for this compound. Eight suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the doxercalciferol profile page.

Summary for NDA: 091433

West-ward Pharms Int
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 091433


Suppliers and Packaging for NDA: 091433

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPSULE;ORAL 091433 ANDA Roxane Laboratories, Inc. 0054-0338 0054-0338-19 50 CAPSULE in 1 BOTTLE (0054-0338-19)
CAPSULE;ORAL 091433 ANDA Roxane Laboratories, Inc. 0054-0339 0054-0339-19 50 CAPSULE in 1 BOTTLE (0054-0339-19)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.5MCG
Approval Date:Sep 23, 2011TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength1MCG
Approval Date:Jan 14, 2014TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength2.5MCG
Approval Date:Jan 14, 2014TE:ABRLD:No

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