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FDA NDA · NDA050632

AZACTAM IN PLASTIC CONTAINER

Sponsor: BRISTOL MYERS SQUIBB

APPLICATION
NDA050632
TYPE
NDA
ORIGINAL APPROVAL
1989-05-24
LATEST ACTION
2018-06-18
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

AZACTAM IN PLASTIC CONTAINER · ReferenceDiscontinued
AZTREONAM 20MG/ML · INJECTABLE · INJECTION
AZACTAM IN PLASTIC CONTAINERDiscontinued
AZTREONAM 10MG/ML · INJECTABLE · INJECTION
AZACTAM IN PLASTIC CONTAINER · ReferenceDiscontinued
AZTREONAM 40MG/ML · INJECTABLE · INJECTION

Approval history

2018-06-18Labeling · Supplement 19 · standard — Letter ↗AP
2014-07-25Manufacturing (CMC) · Supplement 17 · standardAP
2013-07-12Manufacturing (CMC) · Supplement 16 · standardAP
2013-06-17Labeling · Supplement 15 · standard — Letter ↗AP
2008-01-22Labeling · Supplement 13 · standard — Label ↗AP
2004-12-16Labeling · Supplement 12 · standard — Letter ↗AP
2002-03-25Labeling · Supplement 11 · standard — Letter ↗AP
1999-02-16Labeling · Supplement 9 · standardAP
1998-12-24Efficacy · Supplement 10 · standard — Label ↗AP
1996-10-10Manufacturing (CMC) · Supplement 8 · standardAP
1996-08-20Labeling · Supplement 7AP
1996-08-20Labeling · Supplement 6AP
1992-06-25Labeling · Supplement 3AP
1991-09-30Labeling · Supplement 5AP
1989-05-24Type 3 - New Dosage Form · Original · standardAP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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