Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215661
Company: ALEMBIC
Company: ALEMBIC
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 |
---|---|---|---|---|---|---|---|
08/24/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
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 |