Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050611
Company: AZURITY
Company: AZURITY
| 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.html |
| 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 |