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Details for New Drug Application (NDA): 204222

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NDA 204222 describes IBANDRONATE SODIUM, which is a drug marketed by Aurobindo Pharma Ltd, Watson Labs Inc, Apotex Inc, Sagent Pharms, Sun Pharm Inds Ltd, Accord Hlthcare, Mylan Labs Ltd, Emcure Pharms Ltd, Mylan Pharms Inc, Sun Pharm Inds, Dr Reddys Labs Ltd, and Orchid Hlthcare, and is included in fourteen NDAs. It is available from twelve suppliers. Additional details are available on the IBANDRONATE SODIUM profile page.

The generic ingredient in IBANDRONATE SODIUM is ibandronate sodium. There are sixteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the ibandronate sodium profile page.

Summary for NDA: 204222

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 204222

Ingredient-typeDiphosphonates

Suppliers and Packaging for NDA: 204222

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IBANDRONATE SODIUM
ibandronate sodium
INJECTABLE;INTRAVENOUS 204222 ANDA Apotex Corp. 60505-6097 60505-6097-0 1 SYRINGE, GLASS in 1 CARTON (60505-6097-0) > 3 mL in 1 SYRINGE, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 3MG BASE/3ML
Approval Date:Oct 16, 2015TE:APRLD:No
SELECT DISTINCT m.Applicant, m.Tradename, m.Ingredient, m.Dosage, CONCAT(m.NDA,'-',m.Number) AS NDA, m.Approvaldate, p.patentnumber as Patentnumber, a.expiredate as arch_expiredate FROM master m JOIN master_archives a ON (m.NDA = a.NDA and m.Number = a.Number) JOIN patentdetails p ON (a.Patentnumber = p.Patentnumber) WHERE m.NDA = "204222" AND a.expiredate < CURDATE() ORDER BY RAND(104)
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