Details for New Drug Application (NDA): 090654
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NDA 090654 describes METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Alembic, Mylan, and Sun Pharm Inds, and is included in three NDAs. It is available from four 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. Five suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; metoprolol tartrate 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. Five suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; metoprolol tartrate profile page.
Summary for 090654
| Tradename: | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE |
| Applicant: | Sun Pharm Inds |
| Ingredient: | hydrochlorothiazide; metoprolol tartrate |
| Patents: | 0 |
Pharmacology for NDA: 090654
| Mechanism of Action | Adrenergic beta-Antagonists |
| Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 090654
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; metoprolol tartrate | TABLET;ORAL | 090654 | ANDA | Sun Pharmaceutical Industries, Inc. | 62756-368 | 62756-368-08 | 100 TABLET in 1 BOTTLE (62756-368-08) |
| METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; metoprolol tartrate | TABLET;ORAL | 090654 | ANDA | Sun Pharmaceutical Industries, Inc. | 62756-368 | 62756-368-18 | 1000 TABLET in 1 BOTTLE (62756-368-18) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 25MG;50MG | ||||
| Approval Date: | Jan 19, 2012 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 25MG;100MG | ||||
| Approval Date: | Jan 19, 2012 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 50MG;100MG | ||||
| Approval Date: | Jan 19, 2012 | TE: | RLD: | No | |||||
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