Details for New Drug Application (NDA): 090699
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NDA 090699 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 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 090699
| Tradename: | LABETALOL HYDROCHLORIDE |
| Applicant: | Gland Pharma Ltd |
| Ingredient: | labetalol hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 090699
| Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 090699
Suppliers and Packaging for NDA: 090699
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LABETALOL HYDROCHLORIDE | labetalol hydrochloride | INJECTABLE;INJECTION | 090699 | ANDA | Gland Pharma Limited | 68083-111 | 68083-111-01 | 10 VIAL, GLASS in 1 CARTON (68083-111-01) / 20 mL in 1 VIAL, GLASS |
| LABETALOL HYDROCHLORIDE | labetalol hydrochloride | INJECTABLE;INJECTION | 090699 | ANDA | Gland Pharma Limited | 68083-111 | 68083-111-02 | 10 VIAL, GLASS in 1 CARTON (68083-111-02) / 40 mL in 1 VIAL, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5MG/ML | ||||
| Approval Date: | Apr 3, 2012 | TE: | AP | RLD: | No | ||||
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