Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 050611
Company: ARBOR PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PCE ERYTHROMYCIN 333MG TABLET, COATED PARTICLES;ORAL Discontinued None Yes No
PCE ERYTHROMYCIN 500MG TABLET, COATED PARTICLES;ORAL Discontinued None Yes 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
09/09/1986 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
04/23/2018 SUPPL-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050207s074,050611s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050207Orig1s074,050611Orig1s036ltr.pdf
02/02/2012 SUPPL-35 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/2012/050611s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050207s071,050611s035ltr.pdf
12/10/2008 SUPPL-32 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050611s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050611s032ltr.pdf
11/04/2010 SUPPL-31 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050611s031ltr.pdf
05/22/2008 SUPPL-30 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050611s030ltr.pdf
01/05/2008 SUPPL-29 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050611s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050611s029ltr.pdf
01/27/2011 SUPPL-27 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050611s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050611s027ltr.pdf
03/12/2004 SUPPL-24 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50611slr024,50297slr024,50207slr061ltr.pdf
08/09/2006 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050611s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050611s022LTR.pdf
04/25/2002 SUPPL-19 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50207s057.pdf
02/04/2000 SUPPL-18 Labeling Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-207s054s55_50-297s018_50-611s018_Erthromycin.cfm
05/14/1998 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/14/1997 SUPPL-16 Labeling

Label is not available on this site.

01/05/1988 SUPPL-14 Labeling

Label is not available on this site.

05/20/1987 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

05/18/1993 SUPPL-12 Labeling

Label is not available on this site.

08/22/1990 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

09/25/1989 SUPPL-9 Bioequivalence

Label is not available on this site.

07/13/1987 SUPPL-6 Labeling

Label is not available on this site.

10/08/1987 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

05/15/1987 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

02/04/1987 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/25/1989 SUPPL-2 Bioequivalence

Label is not available on this site.

09/25/1989 SUPPL-1 Bioequivalence

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/23/2018 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050207s074,050611s036lbl.pdf
02/02/2012 SUPPL-35 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/2012/050611s035lbl.pdf
01/27/2011 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050611s027lbl.pdf
12/10/2008 SUPPL-32 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050611s032lbl.pdf
01/05/2008 SUPPL-29 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050611s029lbl.pdf
08/09/2006 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050611s022lbl.pdf

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