01 1Johnson & Johnson Innovative Medicine
01 1PALIPERIDONE (R076477) DRUG SUBSTANCE
01 1U.S.A
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-08-31
Pay. Date : 2023-08-16
DMF Number : 18915
Submission : 2005-11-29
Status : Active
Type : II
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Janssen Pharmaceutica Nv, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is PALIPERIDONE (R076477) DRUG SUBSTANCE, with a corresponding US DMF Number 18915.
Remarkably, this DMF maintains an Active status since its submission on November 29, 2005, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 31, 2023, and payment made on August 16, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
