Details for New Drug Application (NDA): 075133
NDA 075133 describes LABETALOL HYDROCHLORIDE, which is a drug marketed by Amneal, Apothecon, Baxter Hlthcare Corp, Caplin, Gland Pharma Ltd, Hikma, Hospira, Onesource Specialty, Rising, Adaptis, Aiping Pharm Inc, Appco, Cadila Pharms Ltd, Epic Pharma Llc, Heritage Pharma, Innogenix, Macleods Pharms Ltd, Ph Health, Rubicon Research, Teva, Unichem, Watson Labs, and Zydus Pharms, and is included in twenty-eight NDAs. It is available from forty-three suppliers. Additional details are available on the LABETALOL HYDROCHLORIDE profile page.
The generic ingredient in LABETALOL HYDROCHLORIDE is labetalol hydrochloride. There is one drug master file entry for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the labetalol hydrochloride profile page.
The generic ingredient in LABETALOL HYDROCHLORIDE is labetalol hydrochloride. There is one drug master file entry for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the labetalol hydrochloride profile page.
Summary for 075133
| Tradename: | LABETALOL HYDROCHLORIDE |
| Applicant: | Watson Labs |
| Ingredient: | labetalol hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 075133
| Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 075133
Suppliers and Packaging for NDA: 075133
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LABETALOL HYDROCHLORIDE | labetalol hydrochloride | TABLET;ORAL | 075133 | ANDA | A-S Medication Solutions | 50090-6778 | 50090-6778-0 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-6778-0) |
| LABETALOL HYDROCHLORIDE | labetalol hydrochloride | TABLET;ORAL | 075133 | ANDA | A-S Medication Solutions | 50090-7156 | 50090-7156-0 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-7156-0) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Aug 3, 1998 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Aug 3, 1998 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
| Approval Date: | Aug 3, 1998 | TE: | AB | RLD: | No | ||||
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