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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050580
Company: BRISTOL MYERS SQUIBB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZACTAM AZTREONAM 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None No No
AZACTAM AZTREONAM 1GM/VIAL INJECTABLE;INJECTION Prescription AP Yes Yes
AZACTAM AZTREONAM 2GM/VIAL INJECTABLE;INJECTION Prescription AP Yes Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/31/1986 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/050580Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/16/2021 SUPPL-46 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050580Orig1s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050580Orig1s046ltr.pdf
06/18/2018 SUPPL-44 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050580s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050580Orig1s044,050632Orig1s019ltr.pdf
09/30/2014 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.
06/17/2013 SUPPL-42 Labeling-Package Insert Label (PDF)
Letter (PDF)
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050580s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050580Orig1s042ltr.pdf
01/22/2008 SUPPL-40 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050580s040,050632s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050580s040ltr.pdf
12/16/2004 SUPPL-37 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50580s037,50632s012ltr.pdf
11/27/2002 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.
09/13/2002 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.
06/24/2002 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.
03/25/2002 SUPPL-33 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50580s033ltr.pdf
12/29/1999 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.
02/16/1999 SUPPL-31 Labeling

Label is not available on this site.
11/07/1997 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.
06/12/1997 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.
02/16/1999 SUPPL-28 Labeling

Label is not available on this site.
07/28/1998 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.
04/03/1996 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.
05/23/1994 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.
02/18/1993 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.
05/23/1994 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.
08/20/1996 SUPPL-22 Labeling

Label is not available on this site.
08/20/1996 SUPPL-21 Labeling

Label is not available on this site.
09/30/1991 SUPPL-20 Labeling

Label is not available on this site.
06/25/1992 SUPPL-19 Labeling

Label is not available on this site.
04/10/1989 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.
09/18/1990 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.
11/01/1996 SUPPL-8 Efficacy-New Indication

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
04/16/2021 SUPPL-46 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050580Orig1s046lbl.pdf
04/16/2021 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050580Orig1s046lbl.pdf
06/18/2018 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050580s044lbl.pdf
06/17/2013 SUPPL-42 Labeling-Package Insert Label (PDF) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050580s042lbl.pdf
01/22/2008 SUPPL-40 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050580s040,050632s013lbl.pdf

AZACTAM

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
AZTREONAM AZTREONAM 1GM/VIAL INJECTABLE;INJECTION Prescription No AP 206517 HOSPIRA

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
AZTREONAM AZTREONAM 2GM/VIAL INJECTABLE;INJECTION Prescription No AP 206517 HOSPIRA
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