Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076174
Company: TARO
Company: TARO
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 |
---|---|---|---|---|---|---|---|
03/13/2003 | 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 |
---|---|---|---|---|---|
04/28/2021 | SUPPL-14 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
05/09/2016 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
03/08/2006 | SUPPL-5 | Labeling |
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 |