01 1Aurobindo Pharma Limited
02 1Hetero Drugs
03 2MSN Laboratories
01 4India
01 3Active
02 1Blank
01 4Blank
01 4Blank
01 1WC-0383
02 3Blank
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GDUFA
DMF Review : Reviewed
Rev. Date : 2019-01-29
Pay. Date : 2018-11-30
DMF Number : 33405
Submission : 2018-12-01
Status : Active
Type : II
NDC Package Code : 59651-274
Start Marketing Date : 2024-01-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/50kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-06-19
Pay. Date : 2018-04-04
DMF Number : 32535
Submission : 2018-03-03
Status : Active
Type : II
Date of Issue : 2019-07-26
Valid Till : 2022-08-08
Written Confirmation Number : WC-0383
Address of the Firm :
NDC Package Code : 69766-046
Start Marketing Date : 2018-03-02
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-07-16
Pay. Date : 2018-04-04
DMF Number : 32562
Submission : 2018-03-21
Status : Active
Type : II
NDC Package Code : 69766-046
Start Marketing Date : 2018-03-02
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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We have 3 companies offering Naloxegol Oxalate
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