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Last Updated: November 25, 2024

Details for New Drug Application (NDA): 091045


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NDA 091045 describes METOPROLOL TARTRATE, which is a drug marketed by Am Regent, Baxter Hlthcare Corp, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hikma Farmaceutica, Hospira, Luitpold, Sandoz, Steriscience Speclts, Watson Labs, Alembic Pharms Ltd, Apothecon, Aurobindo Pharma, Chartwell Rx, Heritage Pharma, Ipca Labs Ltd, Mylan, Norvium Bioscience, Purepac Pharm, Renata, Rubicon, Sun Pharm Inds Inc, Sun Pharm Industries, Teva, Teva Pharms, Youngtech Pharms Inc, Zydus Pharms, Alembic, and Sun Pharm Inds, and is included in thirty-six NDAs. It is available from fifty-six suppliers. Additional details are available on the METOPROLOL TARTRATE profile page.

The generic ingredient in METOPROLOL TARTRATE is hydrochlorothiazide; metoprolol tartrate. There are thirty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; metoprolol tartrate profile page.
Summary for 091045
Tradename:METOPROLOL TARTRATE
Applicant:Fresenius Kabi Usa
Ingredient:metoprolol tartrate
Patents:0
Pharmacology for NDA: 091045
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 091045
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METOPROLOL TARTRATE metoprolol tartrate INJECTABLE;INJECTION 091045 ANDA HF Acquisition Co LLC, DBA HealthFirst 51662-1365 51662-1365-1 5 mL in 1 VIAL (51662-1365-1)
METOPROLOL TARTRATE metoprolol tartrate INJECTABLE;INJECTION 091045 ANDA Fresenius Kabi USA, LLC 63323-660 63323-660-05 10 VIAL in 1 TRAY (63323-660-05) / 5 mL in 1 VIAL (63323-660-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Oct 25, 2010TE:APRLD:No

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