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Generated: January 20, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 080704

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NDA 080704 describes VITAMIN D, which is a drug marketed by Bionpharma Inc, Chase Chem, Everylife, Impax Labs, Lannett, Vitarine, and West Ward, and is included in seven NDAs. It is available from ten suppliers. Additional details are available on the VITAMIN D profile page.

The generic ingredient in VITAMIN D is ergocalciferol. There are six drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the ergocalciferol profile page.
Summary for 080704
Tradename:VITAMIN D
Applicant:Bionpharma Inc
Formulation / Manufacturing:see details
Pharmacology for NDA: 080704
Suppliers and Packaging for NDA: 080704
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VITAMIN D ergocalciferol CAPSULE;ORAL 080704 ANDA AvKARE, Inc. 42291-266 42291-266-01 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (42291-266-01)
VITAMIN D ergocalciferol CAPSULE;ORAL 080704 ANDA PD-Rx Pharmaceuticals, Inc. 43063-711 43063-711-12 12 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (43063-711-12)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50,000 IU
Approval Date:Approved Prior to Jan 1, 1982TE:AARLD:No

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