Details for New Drug Application (NDA): 202871
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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 202871
Tradename: | METOPROLOL TARTRATE |
Applicant: | Alembic Pharms Ltd |
Ingredient: | metoprolol tartrate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 202871
Mechanism of Action | Adrenergic beta-Antagonists |
Suppliers and Packaging for NDA: 202871
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METOPROLOL TARTRATE | metoprolol tartrate | TABLET;ORAL | 202871 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8421 | 0615-8421-05 | 15 TABLET in 1 BLISTER PACK (0615-8421-05) |
METOPROLOL TARTRATE | metoprolol tartrate | TABLET;ORAL | 202871 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8421 | 0615-8421-30 | 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8421-30) / 5 TABLET in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | May 28, 2013 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | May 28, 2013 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | May 28, 2013 | TE: | AB | RLD: | No |
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