Drugs@FDA: FDA-Approved Drugs
Company: AZURITY
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ERYTHROMYCIN | ERYTHROMYCIN | 250MG | TABLET;ORAL | Prescription | AB | No | No |
ERYTHROMYCIN | ERYTHROMYCIN | 500MG | TABLET;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 |
---|---|---|---|---|---|---|---|
07/11/1972 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/061621Orig1s000.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/11/2019 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/061621Orig1s043LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/061621Orig1s043ltr.pdf | |
07/24/2013 | SUPPL-40 | Labeling-Package Insert |
Label is not available on this site. |
||
12/04/2013 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/061621s039lbl.pdf | |
09/24/2009 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
07/02/2009 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
07/03/2006 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
03/17/2004 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
07/18/2000 | SUPPL-29 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
07/26/2000 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/26/2000 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
07/26/2000 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/26/2000 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/26/2000 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
04/20/1998 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/11/2019 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/061621Orig1s043LBL.pdf | |
12/04/2013 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/061621s039lbl.pdf |
ERYTHROMYCIN
TABLET;ORAL; 250MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ERYTHROMYCIN | ERYTHROMYCIN | 250MG | TABLET;ORAL | Prescription | No | AB | 215661 | ALEMBIC |
ERYTHROMYCIN | ERYTHROMYCIN | 250MG | TABLET;ORAL | Prescription | No | AB | 216066 | ALKEM LABS LTD |
ERYTHROMYCIN | ERYTHROMYCIN | 250MG | TABLET;ORAL | Prescription | No | AB | 209720 | AMNEAL PHARMS CO |
ERYTHROMYCIN | ERYTHROMYCIN | 250MG | TABLET;ORAL | Prescription | No | AB | 061621 | AZURITY |
ERYTHROMYCIN | ERYTHROMYCIN | 250MG | TABLET;ORAL | Prescription | No | AB | 213628 | CADILA PHARMS LTD |
ERYTHROMYCIN | ERYTHROMYCIN | 250MG | TABLET;ORAL | Prescription | No | AB | 214549 | TEVA PHARMS USA INC |
ERYTHROMYCIN | ERYTHROMYCIN | 250MG | TABLET;ORAL | Prescription | No | AB | 212015 | TORRENT |
ERYTHROMYCIN | ERYTHROMYCIN | 250MG | TABLET;ORAL | Prescription | No | AB | 212693 | ZYDUS LIFESCIENCES |
TABLET;ORAL; 500MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ERYTHROMYCIN | ERYTHROMYCIN | 500MG | TABLET;ORAL | Prescription | No | AB | 215661 | ALEMBIC |
ERYTHROMYCIN | ERYTHROMYCIN | 500MG | TABLET;ORAL | Prescription | No | AB | 216066 | ALKEM LABS LTD |
ERYTHROMYCIN | ERYTHROMYCIN | 500MG | TABLET;ORAL | Prescription | No | AB | 209720 | AMNEAL PHARMS CO |
ERYTHROMYCIN | ERYTHROMYCIN | 500MG | TABLET;ORAL | Prescription | No | AB | 061621 | AZURITY |
ERYTHROMYCIN | ERYTHROMYCIN | 500MG | TABLET;ORAL | Prescription | No | AB | 213628 | CADILA PHARMS LTD |
ERYTHROMYCIN | ERYTHROMYCIN | 500MG | TABLET;ORAL | Prescription | No | AB | 214549 | TEVA PHARMS USA INC |
ERYTHROMYCIN | ERYTHROMYCIN | 500MG | TABLET;ORAL | Prescription | No | AB | 212015 | TORRENT |
ERYTHROMYCIN | ERYTHROMYCIN | 500MG | TABLET;ORAL | Prescription | No | AB | 212693 | ZYDUS LIFESCIENCES |