Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075074
Company: TARO PHARM INDS
Company: TARO PHARM INDS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ETODOLAC | ETODOLAC | 400MG | TABLET;ORAL | Prescription | AB | No | No |
| ETODOLAC | ETODOLAC | 500MG | TABLET;ORAL | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 03/11/1998 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75074ap.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/28/2021 | SUPPL-26 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/09/2016 | SUPPL-18 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/14/2009 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 11/17/2006 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 03/02/2006 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 05/10/2002 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/11/2002 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/11/2002 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/18/2002 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/25/2000 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 04/25/2000 | SUPPL-1 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
ETODOLAC
TABLET;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;ORAL | Prescription | No | AB | 208834 | AMNEAL PHARMS CO |
| ETODOLAC | ETODOLAC | 400MG | TABLET;ORAL | Prescription | No | AB | 076004 | APOTEX INC |
| ETODOLAC | ETODOLAC | 400MG | TABLET;ORAL | Prescription | No | AB | 210704 | BAYSHORE PHARMS LLC |
| ETODOLAC | ETODOLAC | 400MG | TABLET;ORAL | Prescription | No | AB | 209888 | EDENBRIDGE PHARMS |
| ETODOLAC | ETODOLAC | 400MG | TABLET;ORAL | Prescription | No | AB | 074903 | SANDOZ |
| ETODOLAC | ETODOLAC | 400MG | TABLET;ORAL | Prescription | No | AB | 075074 | TARO PHARM INDS |
TABLET;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;ORAL | Prescription | No | AB | 208834 | AMNEAL PHARMS CO |
| ETODOLAC | ETODOLAC | 500MG | TABLET;ORAL | Prescription | No | AB | 076004 | APOTEX INC |
| ETODOLAC | ETODOLAC | 500MG | TABLET;ORAL | Prescription | No | AB | 210704 | BAYSHORE PHARMS LLC |
| ETODOLAC | ETODOLAC | 500MG | TABLET;ORAL | Prescription | No | AB | 209888 | EDENBRIDGE PHARMS |
| ETODOLAC | ETODOLAC | 500MG | TABLET;ORAL | Prescription | No | AB | 074903 | SANDOZ |
| ETODOLAC | ETODOLAC | 500MG | TABLET;ORAL | Prescription | No | AB | 075074 | TARO PHARM INDS |