01 1FDC
01 1DORZOLAMIDE HYDROCHLORIDE USP (PROCESS II)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-08-26
Pay. Date : 2019-06-21
DMF Number : 33576
Submission : 2019-04-02
Status : Active
Type : II
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Fdc 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 DORZOLAMIDE HYDROCHLORIDE USP (PROCESS II), with a corresponding US DMF Number 33576.
Remarkably, this DMF maintains an Active status since its submission on April 02, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 26, 2019, and payment made on June 21, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II
