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Details for New Drug Application (NDA): 074133

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NDA 074133 describes METOPROLOL TARTRATE, which is a drug marketed by Mylan, Gland Pharma Ltd, Luitpold, Sagent Strides, Watson Labs, Hospira, Teva Pharms, Aurobindo Pharma, Teva, Sun Pharm Inds Inc, Fresenius Kabi Usa, Claris, Mutual Pharm, Prinston Inc, Sun Pharm Inds, Apothecon, Ipca Labs Ltd, Sandoz, Hikma Farmaceutica, Alembic Pharms Ltd, Purepac Pharm, Rubicon Res Pvt Ltd, and Eurohlth Intl Sarl, and is included in thirty-five NDAs. It is available from sixty-three 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. Seven suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; metoprolol tartrate profile page.

Summary for NDA: 074133

Tradename:
METOPROLOL TARTRATE
Applicant:
Hospira
Ingredient:
metoprolol tartrate
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 074133

Mechanism of ActionAdrenergic beta-Antagonists

Suppliers and Packaging for NDA: 074133

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METOPROLOL TARTRATE
metoprolol tartrate
INJECTABLE;INJECTION 074133 ANDA Hospira, Inc. 0409-1778 0409-1778-05 10 VIAL, SINGLE-USE in 1 CARTON (0409-1778-05) > 5 mL in 1 VIAL, SINGLE-USE (0409-1778-15)
METOPROLOL TARTRATE
metoprolol tartrate
INJECTABLE;INJECTION 074133 ANDA Hospira, Inc. 0409-1778 0409-1778-35 3 CARTRIDGE in 1 CARTON (0409-1778-35) > 5 mL in 1 CARTRIDGE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Dec 21, 1993TE:APRLD:No


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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.

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