Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 065246
Company: PLIVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZITHROMYCIN AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION;ORAL Prescription AB No No
AZITHROMYCIN AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION;ORAL Prescription AB 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
07/06/2006 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/065246s000LTR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/28/2017 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

06/28/2017 SUPPL-23 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

06/28/2017 SUPPL-22 Labeling-Package Insert

Label is not available on this site.

06/28/2017 SUPPL-19 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

07/11/2013 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

02/28/2013 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

12/18/2012 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

02/28/2012 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

09/28/2009 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

10/22/2009 SUPPL-5 Labeling

Label is not available on this site.

AZITHROMYCIN

FOR SUSPENSION;ORAL; EQ 200MG BASE/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AZITHROMYCIN AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065488 LUPIN LTD
AZITHROMYCIN AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065246 PLIVA
AZITHROMYCIN AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065419 TEVA PHARMS
ZITHROMAX AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION;ORAL Prescription Yes AB 050710 PFIZER

FOR SUSPENSION;ORAL; EQ 100MG BASE/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AZITHROMYCIN AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065488 LUPIN LTD
AZITHROMYCIN AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065246 PLIVA
AZITHROMYCIN AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065419 TEVA PHARMS
ZITHROMAX AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION;ORAL Prescription Yes AB 050710 PFIZER

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English