Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075855
Company: DR REDDYS LABS LTD
Company: DR REDDYS LABS LTD
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/2001/75855ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/17/2023 | SUPPL-11 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
08/17/2023 | SUPPL-10 | Labeling-Patient Package Insert, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
09/11/2019 | SUPPL-9 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
09/11/2019 | SUPPL-8 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
03/31/2006 | SUPPL-5 | Labeling |
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 | PANGEA |