Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212263
Company: BAYSHORE PHARMS LLC
Company: BAYSHORE PHARMS LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ETODOLAC | ETODOLAC | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| ETODOLAC | ETODOLAC | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| ETODOLAC | ETODOLAC | 600MG | TABLET, EXTENDED 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 |
|---|---|---|---|---|---|---|---|
| 11/24/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
ETODOLAC
TABLET, EXTENDED RELEASE;ORAL; 400MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ETODOLAC | ETODOLAC | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212263 | BAYSHORE PHARMS LLC |
| ETODOLAC | ETODOLAC | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076174 | TARO |
| ETODOLAC | ETODOLAC | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075665 | TEVA |
| ETODOLAC | ETODOLAC | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091134 | ZYDUS PHARMS |
TABLET, EXTENDED RELEASE;ORAL; 500MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ETODOLAC | ETODOLAC | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212263 | BAYSHORE PHARMS LLC |
| ETODOLAC | ETODOLAC | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076174 | TARO |
| ETODOLAC | ETODOLAC | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075665 | TEVA |
| ETODOLAC | ETODOLAC | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091134 | ZYDUS PHARMS |
TABLET, EXTENDED RELEASE;ORAL; 600MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ETODOLAC | ETODOLAC | 600MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212263 | BAYSHORE PHARMS LLC |
| ETODOLAC | ETODOLAC | 600MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076174 | TARO |
| ETODOLAC | ETODOLAC | 600MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075665 | TEVA |
| ETODOLAC | ETODOLAC | 600MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091134 | ZYDUS PHARMS |