Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050632
Company: BRISTOL MYERS SQUIBB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZACTAM IN PLASTIC CONTAINER AZTREONAM 40MG/ML INJECTABLE;INJECTION Prescription None Yes Yes
AZACTAM IN PLASTIC CONTAINER AZTREONAM 20MG/ML INJECTABLE;INJECTION Prescription None Yes Yes
AZACTAM IN PLASTIC CONTAINER AZTREONAM 10MG/ML 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
05/24/1989 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/25/2014 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

07/12/2013 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

06/17/2013 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050632s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050632Orig1s015ltr.pdf
01/22/2008 SUPPL-13 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/2008/050632s013ltr.pdf
12/16/2004 SUPPL-12 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50580s037,50632s012ltr.pdf
03/25/2002 SUPPL-11 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50580s033ltr.pdf
12/24/1998 SUPPL-10 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/50623s10lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/50632s10ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/50632s010.cfm
02/16/1999 SUPPL-9 Labeling

Label is not available on this site.

10/10/1996 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/20/1996 SUPPL-7 Labeling

Label is not available on this site.

08/20/1996 SUPPL-6 Labeling

Label is not available on this site.

09/30/1991 SUPPL-5 Labeling

Label is not available on this site.

06/25/1992 SUPPL-3 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/17/2013 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050632s015lbl.pdf
01/22/2008 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050580s040,050632s013lbl.pdf
12/24/1998 SUPPL-10 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/50623s10lbl.pdf

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