Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075773
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 30MG/VIAL INJECTABLE;INJECTION Prescription AP No No
PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 90MG/VIAL INJECTABLE;INJECTION Prescription AP 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/2001/75773.TA.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075773.PDF
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/05/2002 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

PAMIDRONATE DISODIUM

INJECTABLE;INJECTION; 30MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 30MG/VIAL INJECTABLE;INJECTION Prescription No AP 077433 AREVA PHARMS
PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 30MG/VIAL INJECTABLE;INJECTION Prescription No AP 075773 FRESENIUS KABI USA
PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 30MG/VIAL INJECTABLE;INJECTION Prescription No AP 075290 WEST-WARD PHARMS INT

INJECTABLE;INJECTION; 90MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 90MG/VIAL INJECTABLE;INJECTION Prescription No AP 077433 AREVA PHARMS
PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 90MG/VIAL INJECTABLE;INJECTION Prescription No AP 075773 FRESENIUS KABI USA
PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 90MG/VIAL INJECTABLE;INJECTION Prescription No AP 075290 WEST-WARD PHARMS INT

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