01 1Viwit Pharmaceuticals Limited
01 1VARENICLINE TARTRATE (DRUG SUBSTANCE, NON-STERILE)
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2018-10-31
Pay. Date : 2018-09-11
DMF Number : 32638
Submission : 2018-02-22
Status : Active
Type : II
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Viwit Pharmaceutical Co Ltd, based in China, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is VARENICLINE TARTRATE (DRUG SUBSTANCE, NON-STERILE), with a corresponding US DMF Number 32638.
Remarkably, this DMF maintains an Active status since its submission on February 22, 2018, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 31, 2018, and payment made on September 11, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
