Details for New Drug Application (NDA): 215562
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NDA 215562 describes BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Actavis Elizabeth, Apothecon, Cadila, Chartwell Rx, Edenbridge Pharms, Epic Pharma Llc, Glenmark Pharms Ltd, Ivax Sub Teva Pharms, Mylan, Novitium Pharma, Teva, Unichem, and Watson Labs Teva, and is included in thirteen NDAs. It is available from ten suppliers. Additional details are available on the BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE profile page.
The generic ingredient in BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE is bisoprolol fumarate; hydrochlorothiazide. There are twelve drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the bisoprolol fumarate; hydrochlorothiazide profile page.
The generic ingredient in BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE is bisoprolol fumarate; hydrochlorothiazide. There are twelve drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the bisoprolol fumarate; hydrochlorothiazide profile page.
Summary for 215562
| Tradename: | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE |
| Applicant: | Novitium Pharma |
| Ingredient: | bisoprolol fumarate; hydrochlorothiazide |
| Patents: | 0 |
Pharmacology for NDA: 215562
| Mechanism of Action | Adrenergic beta-Antagonists |
| Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 215562
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | bisoprolol fumarate; hydrochlorothiazide | TABLET;ORAL | 215562 | ANDA | Marlex Pharmaceuticals, Inc. | 10135-740 | 10135-740-01 | 100 TABLET in 1 BOTTLE (10135-740-01) |
| BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | bisoprolol fumarate; hydrochlorothiazide | TABLET;ORAL | 215562 | ANDA | Marlex Pharmaceuticals, Inc. | 10135-740 | 10135-740-05 | 500 TABLET in 1 BOTTLE (10135-740-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG;6.25MG | ||||
| Approval Date: | Nov 4, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG;6.25MG | ||||
| Approval Date: | Nov 4, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG;6.25MG | ||||
| Approval Date: | Nov 4, 2021 | TE: | AB | RLD: | No | ||||
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