Details for New Drug Application (NDA): 200908
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NDA 200908 describes LABETALOL HYDROCHLORIDE, which is a drug marketed by Apothecon, Baxter Hlthcare Corp, Caplin, Gland Pharma Ltd, Hikma, Hospira, Rising, Steriscience, Andas 5 Holding, Appco, Cadila Pharms Ltd, Endo Operations, Epic Pharma Llc, Eywa, Heritage Pharma, Rubicon, Sandoz, Teva, Unichem, Watson Labs, and Zydus Pharms, and is included in twenty-six NDAs. It is available from thirty-nine 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. Thirty-nine 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. Thirty-nine suppliers are listed for this compound. Additional details are available on the labetalol hydrochloride profile page.
Summary for 200908
| Tradename: | LABETALOL HYDROCHLORIDE |
| Applicant: | Endo Operations |
| Ingredient: | labetalol hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 200908
| Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 200908
Suppliers and Packaging for NDA: 200908
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LABETALOL HYDROCHLORIDE | labetalol hydrochloride | TABLET;ORAL | 200908 | ANDA | Endo USA, Inc. | 49884-122 | 49884-122-01 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49884-122-01) |
| LABETALOL HYDROCHLORIDE | labetalol hydrochloride | TABLET;ORAL | 200908 | ANDA | Endo USA, Inc. | 49884-122 | 49884-122-05 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49884-122-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Jul 10, 2012 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Jul 10, 2012 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
| Approval Date: | Jul 10, 2012 | TE: | AB | RLD: | No | ||||
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