Details for New Drug Application (NDA): 201893
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NDA 201893 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 201893
| Tradename: | NADOLOL |
| Applicant: | Aurobindo Pharma |
| Ingredient: | nadolol |
| Patents: | 0 |
Pharmacology for NDA: 201893
| Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 201893
Suppliers and Packaging for NDA: 201893
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NADOLOL | nadolol | TABLET;ORAL | 201893 | ANDA | Aurobindo Pharma Limited | 59651-251 | 59651-251-01 | 100 TABLET in 1 BOTTLE (59651-251-01) |
| NADOLOL | nadolol | TABLET;ORAL | 201893 | ANDA | Aurobindo Pharma Limited | 59651-252 | 59651-252-01 | 100 TABLET in 1 BOTTLE (59651-252-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
| Approval Date: | Sep 16, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 80MG | ||||
| Approval Date: | Sep 16, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Jun 7, 2022 | TE: | AB | RLD: | No | ||||
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