Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210954
Company: AMNEAL PHARMS CO
Company: AMNEAL PHARMS CO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ERYTHROMYCIN | ERYTHROMYCIN | 250MG | TABLET, DELAYED RELEASE;ORAL | Prescription | AB | No | No |
ERYTHROMYCIN | ERYTHROMYCIN | 333MG | TABLET, DELAYED RELEASE;ORAL | Prescription | AB | No | No |
ERYTHROMYCIN | ERYTHROMYCIN | 500MG | 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 |
---|---|---|---|---|---|---|---|
07/02/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
ERYTHROMYCIN
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; 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 |
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 |