01 1Indoco Remedies Limited
01 1BETAXOLOL HYDROCHLORIDE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-07-21
Pay. Date : 2025-07-07
DMF Number : 25301
Submission : 2011-09-22
Status : Active
Type : II
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Indoco Remedies 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 BETAXOLOL HYDROCHLORIDE USP, with a corresponding US DMF Number 25301.
Remarkably, this DMF maintains an Active status since its submission on September 22, 2011, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 21, 2025, and payment made on July 07, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
