Details for New Drug Application (NDA): 218870
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NDA 218870 describes LABETALOL HYDROCHLORIDE, which is a drug marketed by Amneal, Apothecon, Baxter Hlthcare Corp, Caplin, Gland Pharma Ltd, Hikma, Hospira, Onesource Specialty, Rising, Aiping Pharm Inc, Andas 5 Holding, Appco, Cadila Pharms Ltd, Epic Pharma Llc, Heritage Pharma, Hibrow Hlthcare, 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-two 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-two 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-two suppliers are listed for this compound. Additional details are available on the labetalol hydrochloride profile page.
Summary for 218870
| Tradename: | LABETALOL HYDROCHLORIDE |
| Applicant: | Amneal |
| Ingredient: | labetalol hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 218870
| Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 218870
Suppliers and Packaging for NDA: 218870
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LABETALOL HYDROCHLORIDE | labetalol hydrochloride | INJECTABLE;INJECTION | 218870 | ANDA | Amneal Pharmaceuticals LLC | 70121-2428 | 70121-2428-3 | 24 CARTON in 1 CARTON (70121-2428-3) / 1 SYRINGE, GLASS in 1 CARTON (70121-2428-1) / 4 mL in 1 SYRINGE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5MG/ML | ||||
| Approval Date: | Oct 2, 2025 | TE: | AP | RLD: | No | ||||
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