Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075339
Company: NUVO PHARMS INC
Company: NUVO PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SULFASALAZINE | SULFASALAZINE | 500MG | TABLET, DELAYED RELEASE;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 |
---|---|---|---|---|---|---|---|
01/11/2002 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075339.PDF |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/23/2016 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
09/18/2015 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
09/18/2015 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
03/22/2013 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
10/03/2012 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
05/13/2004 | SUPPL-2 | Labeling |
Label is not available on this site. |
SULFASALAZINE
TABLET, DELAYED RELEASE;ORAL; 500MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AZULFIDINE EN-TABS | SULFASALAZINE | 500MG | TABLET, DELAYED RELEASE;ORAL | Prescription | Yes | AB | 007073 | PFIZER |
SULFASALAZINE | SULFASALAZINE | 500MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 075339 | NUVO PHARMS INC |