Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075594
Company: AESGEN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 30MG/VIAL INJECTABLE;INJECTION Discontinued None No No
PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 90MG/VIAL INJECTABLE;INJECTION Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/06/2002 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75594.ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075594.pdf

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