Details for New Drug Application (NDA): 075047
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NDA 075047 describes ACEBUTOLOL HYDROCHLORIDE, which is a drug marketed by Amneal Pharm, Ani Pharms, and Norvium Bioscience, and is included in three NDAs. It is available from six suppliers. Additional details are available on the ACEBUTOLOL HYDROCHLORIDE profile page.
The generic ingredient in ACEBUTOLOL HYDROCHLORIDE is acebutolol hydrochloride. There are nine drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the acebutolol hydrochloride profile page.
The generic ingredient in ACEBUTOLOL HYDROCHLORIDE is acebutolol hydrochloride. There are nine drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the acebutolol hydrochloride profile page.
Summary for 075047
| Tradename: | ACEBUTOLOL HYDROCHLORIDE |
| Applicant: | Amneal Pharm |
| Ingredient: | acebutolol hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 075047
| Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 075047
Suppliers and Packaging for NDA: 075047
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ACEBUTOLOL HYDROCHLORIDE | acebutolol hydrochloride | CAPSULE;ORAL | 075047 | ANDA | AvKARE | 42291-010 | 42291-010-01 | 100 CAPSULE in 1 BOTTLE (42291-010-01) |
| ACEBUTOLOL HYDROCHLORIDE | acebutolol hydrochloride | CAPSULE;ORAL | 075047 | ANDA | AvPAK | 50268-050 | 50268-050-15 | 50 BLISTER PACK in 1 BOX (50268-050-15) / 1 CAPSULE in 1 BLISTER PACK (50268-050-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 200MG BASE | ||||
| Approval Date: | Dec 30, 1999 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 400MG BASE | ||||
| Approval Date: | Dec 30, 1999 | TE: | AB | RLD: | No | ||||
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