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GDUFA
DMF Review : Reviewed
Rev. Date : 2018-05-16
Pay. Date : 2018-03-23
DMF Number : 32519
Submission : 2018-03-20
Status : Active
Type : II
NDC Package Code : 68578-0013
Start Marketing Date : 2018-05-16
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (7kg/1)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-12-30
Pay. Date : 2021-11-16
DMF Number : 36371
Submission : 2021-11-18
Status : Active
Type : II
NDC Package Code : 63850-8098
Start Marketing Date : 2023-11-25
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32434
Submission : 2018-01-23
Status : Inactive
Type : II
A Idelalisib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Idelalisib, including repackagers and relabelers. The FDA regulates Idelalisib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Idelalisib API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Idelalisib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Idelalisib supplier is an individual or a company that provides Idelalisib active pharmaceutical ingredient (API) or Idelalisib finished formulations upon request. The Idelalisib suppliers may include Idelalisib API manufacturers, exporters, distributors and traders.
click here to find a list of Idelalisib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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