01 1Chromo Laboratories
01 1ESOMEPRAZOLE MAGNESIUM TRIHYDRATE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-07-16
Pay. Date : 2025-05-29
DMF Number : 36952
Submission : 2022-07-14
Status : Active
Type : II
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Chromo Laboratories India Private Ltd, based in India, is a pharmaceutical company.
One of their notable products is ESOMEPRAZOLE MAGNESIUM TRIHYDRATE USP, with a corresponding US DMF Number 36952.
Remarkably, this DMF maintains an Active status since its submission on July 14, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 16, 2025, and payment made on May 29, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
