01 1Macleods Pharmaceuticals Limited
01 1LABETALOL HYDROCHLORIDE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-02-01
Pay. Date : 2021-01-19
DMF Number : 34099
Submission : 2020-01-27
Status : Active
Type : II
20
Macleods Pharmaceuticals Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
One of their notable products is LABETALOL HYDROCHLORIDE USP, with a corresponding US DMF Number 34099.
Remarkably, this DMF maintains an Active status since its submission on January 27, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 01, 2021, and payment made on January 19, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
