Details for New Drug Application (NDA): 210955
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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 210955
Tradename: | NADOLOL |
Applicant: | Beximco Pharms Usa |
Ingredient: | nadolol |
Patents: | 0 |
Pharmacology for NDA: 210955
Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 210955
Suppliers and Packaging for NDA: 210955
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NADOLOL | nadolol | TABLET;ORAL | 210955 | ANDA | Marlex Pharmaceuticals Inc | 10135-686 | 10135-686-01 | 100 TABLET in 1 BOTTLE (10135-686-01) |
NADOLOL | nadolol | TABLET;ORAL | 210955 | ANDA | Marlex Pharmaceuticals Inc | 10135-687 | 10135-687-01 | 100 TABLET in 1 BOTTLE (10135-687-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Jul 23, 2018 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
Approval Date: | Jul 23, 2018 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 80MG | ||||
Approval Date: | Jul 23, 2018 | TE: | AB | RLD: | No |
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