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Details for New Drug Application (NDA): 080704

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

The generic ingredient in VITAMIN D is ergocalciferol. There are five drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the ergocalciferol profile page.

Summary for NDA: 080704

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
CAPSULE;ORAL 080704 ANDA AvKARE, Inc. 42291-266 42291-266-01 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (42291-266-01)
CAPSULE;ORAL 080704 ANDA PD-Rx Pharmaceuticals, Inc. 43063-711 43063-711-12 12 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (43063-711-12)

Summary 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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