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Generated: March 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078459

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NDA 078459 describes METOPROLOL TARTRATE, which is a drug marketed by Baxter Hlthcare Corp, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira, Luitpold, Mylan Asi, Sandoz Inc, Watson Labs, West-ward Pharms Int, Alembic Pharms Ltd, Apothecon, Aurobindo Pharma, Ipca Labs Ltd, Mylan, Purepac Pharm, Renata, Rubicon Res Pvt Ltd, Sun Pharm Inds Inc, Sun Pharm Industries, Teva, Teva Pharms, Yaopharma Co Ltd, and Sun Pharm Inds, and is included in thirty-four NDAs. It is available from sixty-two suppliers. Additional details are available on the METOPROLOL TARTRATE profile page.

The generic ingredient in METOPROLOL TARTRATE is hydrochlorothiazide; metoprolol tartrate. There are thirty-one drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; metoprolol tartrate profile page.
Summary for 078459
Applicant:Ipca Labs Ltd
Ingredient:metoprolol tartrate
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078459
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 078459
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METOPROLOL TARTRATE metoprolol tartrate TABLET;ORAL 078459 ANDA Major Pharmaceuticals 0904-6162 E 0904-6162-61
METOPROLOL TARTRATE metoprolol tartrate TABLET;ORAL 078459 ANDA Unit Dose Services 50436-3155 N 50436-3155-2

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Jun 17, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jun 17, 2008TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Jun 17, 2008TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

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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.