Drugs@FDA: FDA-Approved Drugs
Company: AZURITY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ERY-TAB | ERYTHROMYCIN | 250MG | TABLET, DELAYED RELEASE;ORAL | Prescription | AB | No | No |
| ERY-TAB | ERYTHROMYCIN | 500MG | TABLET, DELAYED RELEASE;ORAL | Prescription | AB | No | Yes |
| ERY-TAB | ERYTHROMYCIN | 333MG | TABLET, DELAYED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 03/29/1982 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/28/2019 | SUPPL-72 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/05/2013 | SUPPL-69 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/04/2013 | SUPPL-68 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/062298s068lbl.pdf | |
| 09/24/2009 | SUPPL-67 | Labeling |
Label is not available on this site. |
||
| 07/02/2009 | SUPPL-66 | Labeling |
Label is not available on this site. |
||
| 05/18/2006 | SUPPL-63 | Labeling |
Label is not available on this site. |
||
| 03/17/2004 | SUPPL-61 | Labeling |
Label is not available on this site. |
||
| 11/20/2002 | SUPPL-56 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/12/2002 | SUPPL-55 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/21/2001 | SUPPL-54 | Labeling |
Label is not available on this site. |
||
| 06/08/1999 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/16/1999 | SUPPL-52 | Labeling |
Label is not available on this site. |
||
| 09/16/1999 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/16/1999 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/08/1999 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/20/1998 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/22/1998 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
| 09/22/1998 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/22/1998 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/22/1998 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/22/1998 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/20/1990 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/08/1989 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/29/1990 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/17/1989 | 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 |
|---|---|---|---|---|---|
| 12/04/2013 | SUPPL-68 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/062298s068lbl.pdf |
ERY-TAB
TABLET, DELAYED RELEASE;ORAL; 250MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ERY-TAB | ERYTHROMYCIN | 250MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 062298 | AZURITY |
| ERYTHROMYCIN | ERYTHROMYCIN | 250MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 210954 | AMNEAL PHARMS CO |
| ERYTHROMYCIN | ERYTHROMYCIN | 250MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 211975 | TORRENT |
TABLET, DELAYED RELEASE;ORAL; 500MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ERY-TAB | ERYTHROMYCIN | 500MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 062298 | AZURITY |
| ERYTHROMYCIN | ERYTHROMYCIN | 500MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 210954 | AMNEAL PHARMS CO |
| ERYTHROMYCIN | ERYTHROMYCIN | 500MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 211975 | TORRENT |
TABLET, DELAYED RELEASE;ORAL; 333MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ERY-TAB | ERYTHROMYCIN | 333MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 062298 | AZURITY |
| ERYTHROMYCIN | ERYTHROMYCIN | 333MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 210954 | AMNEAL PHARMS CO |