Details for New Drug Application (NDA): 209603
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NDA 209603 describes LABETALOL HYDROCHLORIDE, which is a drug marketed by Amneal, Apothecon, Baxter Hlthcare Corp, Caplin, Gland Pharma Ltd, Hikma, Hospira, Onesource Specialty, Rising, Andas 5 Holding, Appco, Cadila Pharms Ltd, Epic Pharma Llc, Heritage Pharma, Hibrow Hlthcare, Macleods Pharms Ltd, Ph Health, Rubicon Research, Sandoz, 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 are fourteen drug master file entries 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 are fourteen drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the labetalol hydrochloride profile page.
Summary for 209603
| Tradename: | LABETALOL HYDROCHLORIDE |
| Applicant: | Appco |
| Ingredient: | labetalol hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 209603
| Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 209603
Suppliers and Packaging for NDA: 209603
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LABETALOL HYDROCHLORIDE | labetalol hydrochloride | TABLET;ORAL | 209603 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8512 | 0615-8512-39 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8512-39) |
| LABETALOL HYDROCHLORIDE | labetalol hydrochloride | TABLET;ORAL | 209603 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8513 | 0615-8513-39 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8513-39) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Jun 20, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Jun 20, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
| Approval Date: | Jun 20, 2018 | TE: | AB | RLD: | No | ||||
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