Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075419
Company: APOTEX
Company: APOTEX
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 | 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 |
---|---|---|---|---|---|---|---|
07/28/2000 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75419ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/08/2024 | SUPPL-15 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
04/29/2021 | SUPPL-13 | Labeling-Package Insert, Labeling-Medication Guide |
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. |
||
02/07/2013 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
04/25/2006 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
11/15/2001 | 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 | 205448 | IPCA LABS LTD |
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 | 205448 | IPCA LABS LTD |
ETODOLAC | ETODOLAC | 300MG | CAPSULE;ORAL | Prescription | No | AB | 075078 | TARO |