Details for New Drug Application (NDA): 078688
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NDA 078688 describes NADOLOL AND BENDROFLUMETHIAZIDE, which is a drug marketed by Impax Labs and Natco Pharma and is included in two NDAs. Additional details are available on the NADOLOL AND BENDROFLUMETHIAZIDE profile page.
The generic ingredient in NADOLOL AND BENDROFLUMETHIAZIDE is bendroflumethiazide; nadolol. There are four drug master file entries for this compound. Additional details are available on the bendroflumethiazide; nadolol profile page.
The generic ingredient in NADOLOL AND BENDROFLUMETHIAZIDE is bendroflumethiazide; nadolol. There are four drug master file entries for this compound. Additional details are available on the bendroflumethiazide; nadolol profile page.
Summary for 078688
| Tradename: | NADOLOL AND BENDROFLUMETHIAZIDE |
| Applicant: | Natco Pharma |
| Ingredient: | bendroflumethiazide; nadolol |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 5MG;40MG | ||||
| Approval Date: | Feb 15, 2008 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 5MG;80MG | ||||
| Approval Date: | Feb 15, 2008 | TE: | RLD: | No | |||||
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