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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050632
Company: BRISTOL MYERS SQUIBB

Products on NDA 050632

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AZACTAM IN PLASTIC CONTAINER	AZTREONAM	40MG/ML	INJECTABLE;INJECTION	Discontinued	None	Yes	No
AZACTAM IN PLASTIC CONTAINER	AZTREONAM	20MG/ML	INJECTABLE;INJECTION	Discontinued	None	Yes	No
AZACTAM IN PLASTIC CONTAINER	AZTREONAM	10MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050632

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
06/18/2018	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050632s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050580Orig1s044,050632Orig1s019ltr.pdf
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)	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/2013/050632s015lbl.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.

Labels for NDA 050632

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/18/2018	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050632s019lbl.pdf
06/17/2013	SUPPL-15	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/2013/050632s015lbl.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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