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01 1Fermion Oy
02 1Alkaloida Chemical Company Zrt
03 1Apotex Pharmachem
04 1Archimica
05 1Cyclo Industries
06 1Emcure Pharmaceuticals
07 1Fareva
08 1Industriale Chimica
09 1Maithri Drugs
10 1Solara Active Pharma Sciences
11 1Southwest Synthetic Pharmaceutical
12 1Unichem Laboratories Limited
13 1Unimark Remedies Limited
14 1Zydus Lifesciences
15 3Blank
01 1BUSPIRONE HCL
02 10BUSPIRONE HYDROCHLORIDE
03 6BUSPIRONE HYDROCHLORIDE USP
01 1Canada
02 1China
03 1Finland
04 1Hungary
05 6India
06 2Italy
07 1Luxembourg
08 1U.S.A
09 3Blank
01 8Active
02 9Inactive
01 8Complete
02 9Blank
GDUFA
DMF Review : Complete
Rev. Date : 2016-07-28
Pay. Date : 2016-07-21
DMF Number : 11148
Submission : 1994-10-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-07-12
Pay. Date : 2023-05-26
DMF Number : 38412
Submission : 2023-05-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-04
Pay. Date : 2013-09-26
DMF Number : 9167
Submission : 1991-06-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-10-06
Pay. Date : 2023-08-29
DMF Number : 38109
Submission : 2023-03-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-09
Pay. Date : 2023-09-28
DMF Number : 35488
Submission : 2020-12-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-23
Pay. Date : 2015-09-16
DMF Number : 29704
Submission : 2015-09-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-13
Pay. Date : 2014-01-20
DMF Number : 25361
Submission : 2011-11-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-02-25
Pay. Date : 2018-12-20
DMF Number : 33431
Submission : 2018-12-28
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5397
Submission : 1984-05-21
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4241
Submission : 1981-07-29
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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