Details for New Drug Application (NDA): 203455
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NDA 203455 describes NADOLOL, which is a drug marketed by Alembic, Amneal Pharms Co, Aurobindo Pharma, Beximco Pharms Usa, Chartwell Rx, Heritage Pharma, Invagen Pharms, Novast Labs, Rising, Rk Pharma, Sandoz, Teva Pharms, Zydus Pharms, Impax Labs, and Natco Pharma, and is included in sixteen NDAs. It is available from fifteen suppliers. Additional details are available on the NADOLOL profile page.
The generic ingredient in NADOLOL 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 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 203455
| Tradename: | NADOLOL |
| Applicant: | Invagen Pharms |
| Ingredient: | nadolol |
| Patents: | 0 |
Pharmacology for NDA: 203455
| Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 203455
Suppliers and Packaging for NDA: 203455
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NADOLOL | nadolol | TABLET;ORAL | 203455 | ANDA | Major Pharmaceuticals | 0904-7070 | 0904-7070-07 | 30 BLISTER PACK in 1 CARTON (0904-7070-07) / 1 TABLET in 1 BLISTER PACK |
| NADOLOL | nadolol | TABLET;ORAL | 203455 | ANDA | Major Pharmaceuticals | 0904-7070 | 0904-7070-61 | 100 BLISTER PACK in 1 CARTON (0904-7070-61) / 1 TABLET in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Dec 18, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
| Approval Date: | Dec 18, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 80MG | ||||
| Approval Date: | Dec 18, 2015 | TE: | AB | RLD: | No | ||||
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