.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206058

« Back to Dashboard
NDA 206058 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 thirteen 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. Fifteen 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: 206058

Tradename:
IBANDRONATE SODIUM
Applicant:
Accord Hlthcare
Ingredient:
ibandronate sodium
Patents:0
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 206058

Ingredient-typeDiphosphonates

Suppliers and Packaging for NDA: 206058

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IBANDRONATE SODIUM
ibandronate sodium
INJECTABLE;INTRAVENOUS 206058 ANDA Accord Healthcare Inc. 16729-274 16729-274-74 1 SYRINGE, GLASS in 1 CARTON (16729-274-74) > 3 mL in 1 SYRINGE, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 3MG BASE/3ML
Approval Date:Feb 5, 2016TE:APRLD:No


Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

`abc