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01 1Jai Radhe Sales
02 1Aurobindo Pharma Limited
03 1Bio-gen Extracts
04 1FUKUZYU PHARMACEUTICAL CO LTD
05 1Fera Pharmaceuticals, LLC
06 1Hikal
07 1Interquim Mexico
08 1Ipca Laboratories
09 1Mangalam Drugs & Organics Ltd
10 1National Institutes of Health
11 1Nishchem International Pvt. Ltd
12 3R L Fine Chem
01 10India
02 1Japan
03 1Mexico
04 2U.S.A
01 5Active
02 1Inactive
03 8Blank
01 2Valid
02 12Blank
01 14Blank
01 1WC-0091
02 1WC-0094nA2A
03 1WC-0139
04 1WC-0445A2
05 1WC-0445A3
06 1WC-0473
07 8Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-11-27
Pay. Date : 2013-08-21
DMF Number : 22880
Submission : 2009-06-26
Status : Active
Type : II
Certificate Number : R1-CEP 2009-183 - Rev 02
Issue Date : 2019-03-28
Type : Chemical
Substance Number : 288
Status : Valid
Date of Issue : 2022-06-08
Valid Till : 2025-07-02
Written Confirmation Number : WC-0091
Address of the Firm :
NDC Package Code : 57451-1183
Start Marketing Date : 2019-11-12
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9998
Submission : 1992-11-26
Status : Active
Type : II
NDC Package Code : 68057-001
Start Marketing Date : 2013-08-22
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-11-13
Pay. Date : 2020-09-01
DMF Number : 35121
Submission : 2020-08-14
Status : Active
Type : II
Certificate Number : R0-CEP 2022-045 - Rev 00
Issue Date : 2023-08-23
Type : Chemical
Substance Number : 288
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-06-24
Pay. Date : 2019-05-24
DMF Number : 33759
Submission : 2019-05-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 105
Submission : 1940-01-01
Status : Inactive
Type : II
Date of Issue : 2020-06-11
Valid Till : 2023-06-10
Written Confirmation Number : WC-0473
Address of the Firm :
Date of Issue : 2020-03-31
Valid Till : 2022-07-28
Written Confirmation Number : WC-0445A3
Address of the Firm :
NDC Package Code : 71554-020
Start Marketing Date : 2020-10-23
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2020-03-31
Valid Till : 2022-07-28
Written Confirmation Number : WC-0445A2
Address of the Firm :
NDC Package Code : 71554-020
Start Marketing Date : 2020-10-23
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2022-06-14
Valid Till : 2025-09-02
Written Confirmation Number : WC-0094nA2A
Address of the Firm :
NDC Package Code : 66651-922
Start Marketing Date : 2017-12-15
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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