Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075226
Company: RANBAXY LABS LTD
Company: RANBAXY LABS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ETODOLAC | ETODOLAC | 400MG | TABLET;ORAL | Discontinued | None | No | No |
ETODOLAC | ETODOLAC | 500MG | TABLET;ORAL | Discontinued | None | 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 |
---|---|---|---|---|---|---|---|
11/24/1998 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75226ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/22/2001 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
02/08/2001 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/20/2000 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/20/2000 | SUPPL-2 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |