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Generated: February 17, 2019

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Details for New Drug Application (NDA): 091004

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NDA 091004 describes ERGOCALCIFEROL, which is a drug marketed by Orit Labs Llc, Puracap Pharm Llc, Sigmapharm Labs Llc, Strides Pharma, and Sun Pharm Inds Inc, and is included in five NDAs. It is available from twenty-two suppliers. Additional details are available on the ERGOCALCIFEROL profile page.

The generic ingredient in ERGOCALCIFEROL is ergocalciferol. There are six drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the ergocalciferol profile page.
Summary for 091004
Applicant:Sigmapharm Labs Llc
Formulation / Manufacturing:see details
Pharmacology for NDA: 091004
Suppliers and Packaging for NDA: 091004
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ERGOCALCIFEROL ergocalciferol CAPSULE;ORAL 091004 ANDA SigmaPharm Laboratories, LLC 42794-006 42794-006-02 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (42794-006-02)
ERGOCALCIFEROL ergocalciferol CAPSULE;ORAL 091004 ANDA Proficient Rx LP 63187-064 63187-064-30 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (63187-064-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50,000 IU
Approval Date:Jul 14, 2010TE:AARLD:No

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