Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065439
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZTREONAM AZTREONAM 500MG/VIAL INJECTABLE;INJECTION Prescription None No No
AZTREONAM AZTREONAM 1GM/VIAL INJECTABLE;INJECTION Prescription AP No No
AZTREONAM AZTREONAM 2GM/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
06/18/2010 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/065439Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/28/2015 SUPPL-5 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

04/28/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

AZTREONAM

INJECTABLE;INJECTION; 1GM/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AZACTAM AZTREONAM 1GM/VIAL INJECTABLE;INJECTION Prescription Yes AP 050580 BRISTOL MYERS SQUIBB
AZTREONAM AZTREONAM 1GM/VIAL INJECTABLE;INJECTION Prescription No AP 065439 FRESENIUS KABI USA

INJECTABLE;INJECTION; 2GM/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AZACTAM AZTREONAM 2GM/VIAL INJECTABLE;INJECTION Prescription Yes AP 050580 BRISTOL MYERS SQUIBB
AZTREONAM AZTREONAM 2GM/VIAL INJECTABLE;INJECTION Prescription No AP 065439 FRESENIUS KABI USA

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