FDA NDA · NDA050797

ZMAX

Sponsor: PF PRISM CV

APPLICATION

NDA050797

TYPE

NDA

ORIGINAL APPROVAL

2005-06-10

LATEST ACTION

2021-11-22

ROUTE

ORAL

DOSAGE FORM

FOR SUSPENSION, EXTENDED RELEASE

MARKETING STATUS

Discontinued

Products

ZMAX · ReferenceDiscontinued

AZITHROMYCIN EQ 2GM BASE/BOT · FOR SUSPENSION, EXTENDED RELEASE · ORAL

2021-11-22Labeling · Supplement 26 · standard — Letter ↗AP

2019-04-24Labeling · Supplement 25 · standard — Letter ↗AP

2017-03-30Labeling · Supplement 24 · standard — Label ↗AP

2017-02-09Labeling · Supplement 21 · standard — Label ↗AP

2016-06-27Manufacturing (CMC) · Supplement 22 · standardAP

2016-05-24Labeling · Supplement 20 · standard — Label ↗AP

2015-07-02Labeling · Supplement 19 · standard — Label ↗AP

2013-10-11Labeling · Supplement 13 · standard — Label ↗AP

2013-02-19Labeling · Supplement 17 · standard — Label ↗AP

2012-03-01Labeling · Supplement 16 · standard — Label ↗AP

2011-06-07Labeling · Supplement 14 · standard — Label ↗AP

2011-06-07Labeling · Supplement 12 · unknown — Label ↗AP

2011-06-07Labeling · Supplement 10 · unknown — Letter ↗AP

2008-10-07Efficacy · Supplement 8 · unknown — Pediatric Medical Review ↗AP

2007-10-25Labeling · Supplement 1 · standard — Label ↗AP

2005-06-10Type 3 - New Dosage Form · Original · standard — Review ↗AP

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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