| Product Information |
DR-XY48744_PI_01.pdf
|
| Registration Number |
DR-XY48744
|
| Generic Name |
Labetalol Hydrochloride
|
| Brand Name |
Betalex
|
| Dosage Strength |
5 mg/mL (20 mg/4 mL)
|
| Dosage Form |
Solution for Injection (IV)
|
| Classification |
Prescription (Rx) Drug
|
| Pharmacologic Category |
-
|
| Packaging |
4 mL net content in 5 mL-capacity USP Type I Clear glass ampoule with double red ring (Box of 5's)
|
| Manufacturer |
United Biotech Pvt. Ltd.
|
| Country of Origin |
India
|
| Trader |
|
| Importer |
Delex Pharma International, Inc.
|
| Distributor |
Delex Pharma International, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
25 May 2023
|
| Expiry Date |
25 May 2028
|