01 1Aurobindo Pharma Limited
02 1Emcure Pharmaceuticals
03 2Hetero Drugs
04 2Lupin Ltd
05 1Maithri Drugs
06 2Viatris
01 3RALTEGRAVIR POTASSIUM
02 1RALTEGRAVIR POTASSIUM (FORM-III)
03 3RALTEGRAVIR POTASSIUM USP
04 1RALTEGRAVIR POTASSIUM USP (CRYSTALLINE)
05 1RALTEGRAVIR POTASSIUM USP (PROCESS-II)
01 7India
02 2U.S.A
01 7Active
02 2Inactive
01 5Complete
02 4Blank
GDUFA
DMF Review : Complete
Rev. Date : 2024-02-14
Pay. Date : 2023-12-22
DMF Number : 39315
Submission : 2023-12-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26935
Submission : 2013-03-28
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-02-08
Pay. Date : 2023-01-10
DMF Number : 37182
Submission : 2022-12-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25261
Submission : 2011-09-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-09-15
Pay. Date : 2022-08-25
DMF Number : 34206
Submission : 2019-09-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25753
Submission : 2012-04-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36083
Submission : 2021-06-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-09-02
Pay. Date : 2016-06-21
DMF Number : 30595
Submission : 2016-06-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-31
Pay. Date : 2013-12-09
DMF Number : 27728
Submission : 2013-12-24
Status : Active
Type : II
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