Health Pharmacy Question: Download Health Pharmacy PDF
Which type of data need to file ANDA submission in USA ?
Answer:
information on drug substance- API (DMF)+ EXCIPIENTS
INFORMATION ON FINISHED PRODUCT, MANUFACTURING AND PACKAGING
(CMC)
INFORMATION ON DEVELOPMENT (R&D)
INFORMATION ON STABILITY OF FINISHED PODUCT
LABELING
INFORMATION ON FINISHED PRODUCT, MANUFACTURING AND PACKAGING
(CMC)
INFORMATION ON DEVELOPMENT (R&D)
INFORMATION ON STABILITY OF FINISHED PODUCT
LABELING
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