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Last Updated: September 25, 2020

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Details for New Drug Application (NDA): 202870

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NDA 202870 describes METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Alembic Pharms Ltd, Mylan, and Sun Pharm Inds, and is included in three NDAs. It is available from three suppliers. Additional details are available on the METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; metoprolol tartrate. There are thirty-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; metoprolol tartrate profile page.
Pharmacology for NDA: 202870
Mechanism of ActionAdrenergic beta-Antagonists
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 202870
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; metoprolol tartrate TABLET;ORAL 202870 ANDA Alembic Pharmaceuticals Limited 46708-115 46708-115-01 1000 TABLET in 1 BOTTLE (46708-115-01)
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; metoprolol tartrate TABLET;ORAL 202870 ANDA Alembic Pharmaceuticals Limited 46708-115 46708-115-10 100 TABLET in 1 BOTTLE (46708-115-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;50MG
Approval Date:Nov 6, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;100MG
Approval Date:Nov 6, 2013TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG;100MG
Approval Date:Nov 6, 2013TE:ABRLD:No

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