Details for New Drug Application (NDA): 075223
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NDA 075223 describes LABETALOL HYDROCHLORIDE, which is a drug marketed by Apothecon, Baxter Hlthcare Corp, Caplin, Gland Pharma Ltd, Hikma, Hospira, Rising, Steriscience Speclts, Andas 5 Holding, Appco, Cadila Pharms Ltd, Endo Operations, Epic Pharma Llc, Heritage Pharma, Hibrow Hlthcare, Rubicon, Sandoz, Teva, Unichem, Watson Labs, and Zydus Pharms, and is included in twenty-six NDAs. It is available from forty suppliers. Additional details are available on the LABETALOL HYDROCHLORIDE profile page.
The generic ingredient in LABETALOL HYDROCHLORIDE is labetalol hydrochloride. There are fourteen drug master file entries for this compound. Forty 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 are fourteen drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the labetalol hydrochloride profile page.
Summary for 075223
| Tradename: | LABETALOL HYDROCHLORIDE |
| Applicant: | Apothecon |
| Ingredient: | labetalol hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 075223
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Nov 20, 1998 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Nov 20, 1998 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
| Approval Date: | Nov 20, 1998 | TE: | RLD: | No | |||||
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