01 1MSN Laboratories
01 1ROFLUMILAST [ROUTE CODE - RO"]
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-27
Pay. Date : 2014-07-03
DMF Number : 27612
Submission : 2013-11-30
Status : Active
Type : II
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Msn Laboratories Private Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is ROFLUMILAST [ROUTE CODE - RO"], with a corresponding US DMF Number 27612.
Remarkably, this DMF maintains an Active status since its submission on November 30, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 27, 2014, and payment made on July 03, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
