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FDA NDA · NDA050762

TROVAN/ZITHROMAX COMPLIANCE PAK

Sponsor: PFIZER

APPLICATION
NDA050762
TYPE
NDA
ORIGINAL APPROVAL
1998-12-18
LATEST ACTION
1998-12-18
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION, TABLET
MARKETING STATUS
Discontinued

Products

TROVAN/ZITHROMAX COMPLIANCE PAKDiscontinued
AZITHROMYCIN DIHYDRATE EQ 1GM BASE,N/A, TROVAFLOXACIN MESYLATE N/A,EQ 100MG BASE · FOR SUSPENSION, TABLET · ORAL

Approval history

1998-12-18Type 4 - New Combination · Original · standardReviewAP
VIEW ON DRUGS@FDA ↗

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