Drugs@FDA: FDA-Approved Drugs
Company: TEVA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ETODOLAC | ETODOLAC | 600MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | Yes |
ETODOLAC | ETODOLAC | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
ETODOLAC | ETODOLAC | 400MG | 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 |
---|---|---|---|---|---|---|---|
07/31/2000 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75665ltrTA.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/28/2021 | SUPPL-13 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
05/09/2016 | SUPPL-9 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
08/14/2006 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
03/02/2006 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
04/19/2001 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/05/2001 | SUPPL-3 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75665S1,2,3ltr.pdf |
02/05/2001 | SUPPL-2 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75665S1,2,3ltr.pdf |
02/05/2001 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75665S1,2,3ltr.pdf |
ETODOLAC
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 |
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; 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 |