Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075078
Company: TARO
Company: TARO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ETODOLAC | ETODOLAC | 200MG | CAPSULE;ORAL | Prescription | AB | No | No |
| ETODOLAC | ETODOLAC | 300MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 04/30/1998 | ORIG-1 | Approval |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75078.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/28/2021 | SUPPL-17 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 05/09/2016 | SUPPL-12 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/14/2009 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 11/17/2006 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 03/02/2006 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 09/11/2002 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/11/2002 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 01/29/2002 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/20/2002 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
ETODOLAC
CAPSULE;ORAL; 200MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ETODOLAC | ETODOLAC | 200MG | CAPSULE;ORAL | Prescription | No | AB | 075126 | ANI PHARMS |
| ETODOLAC | ETODOLAC | 200MG | CAPSULE;ORAL | Prescription | No | AB | 075419 | APOTEX |
| ETODOLAC | ETODOLAC | 200MG | CAPSULE;ORAL | Prescription | No | AB | 075078 | TARO |
CAPSULE;ORAL; 300MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ETODOLAC | ETODOLAC | 300MG | CAPSULE;ORAL | Prescription | No | AB | 075126 | ANI PHARMS |
| ETODOLAC | ETODOLAC | 300MG | CAPSULE;ORAL | Prescription | No | AB | 075419 | APOTEX |
| ETODOLAC | ETODOLAC | 300MG | CAPSULE;ORAL | Prescription | No | AB | 075078 | TARO |