01 1Raks Pharma
01 1DOXEPIN HYDROCHLORIDE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2020-09-15
Pay. Date : 2020-07-27
DMF Number : 35017
Submission : 2020-08-08
Status : Active
Type : II
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Raks Pharma Pvt Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and WHO-GMP.
One of their notable products is DOXEPIN HYDROCHLORIDE USP, with a corresponding US DMF Number 35017.
Remarkably, this DMF maintains an Active status since its submission on August 08, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 15, 2020, and payment made on July 27, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
