Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075845
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OXAPROZIN | OXAPROZIN | 600MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 01/31/2001 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75845ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/14/2023 | SUPPL-28 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/14/2023 | SUPPL-26 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/27/2019 | SUPPL-22 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 08/27/2019 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/01/2012 | SUPPL-13 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/29/2006 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 02/07/2006 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 03/17/2005 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 06/13/2002 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 06/13/2002 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
OXAPROZIN
TABLET;ORAL; 600MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DAYPRO | OXAPROZIN | 600MG | TABLET;ORAL | Prescription | Yes | AB | 018841 | PFIZER |
| OXAPROZIN | OXAPROZIN | 600MG | TABLET;ORAL | Prescription | No | AB | 208633 | AMNEAL PHARMS CO |
| OXAPROZIN | OXAPROZIN | 600MG | TABLET;ORAL | Prescription | No | AB | 075987 | CHARTWELL |
| OXAPROZIN | OXAPROZIN | 600MG | TABLET;ORAL | Prescription | No | AB | 075855 | DR REDDYS LABS LTD |
| OXAPROZIN | OXAPROZIN | 600MG | TABLET;ORAL | Prescription | No | AB | 075845 | SANDOZ |