Application 007073
- Type
- NDA
- Sponsor
- PHARMACIA AND UPJOHN
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | AZULFIDINE | SULFASALAZINE | TABLET;ORAL | 500MG | Yes | Yes |
| 002 | AZULFIDINE EN-TABS | SULFASALAZINE | TABLET, DELAYED RELEASE;ORAL | 500MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0013-0101 | Azulfidine | Sulfasalazine | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0013-0101 | Azulfidine | Sulfasalazine | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0013-0101 | Azulfidine | Sulfasalazine | Pharmacia and Upjohn Comp | NDA | Current |
| 0013-0101 | Azulfidine | Sulfasalazine | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0013-0101 | Azulfidine | Sulfasalazine | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0013-0101 | Azulfidine | Sulfasalazine | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0013-0101 | Azulfidine | Sulfasalazine | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0013-0101 | Azulfidine | Sulfasalazine | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0013-0101 | Azulfidine | Sulfasalazine | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0013-0102 | Azulfidine | Sulfasalazine | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0013-0102 | Azulfidine | Sulfasalazine | Pharmacia and Upjohn Comp | NDA | Current |
| 0013-0102 | Azulfidine | Sulfasalazine | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0013-0102 | Azulfidine | Sulfasalazine | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0013-0102 | Azulfidine | Sulfasalazine | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0013-0102 | Azulfidine | Sulfasalazine | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0013-0102 | Azulfidine | Sulfasalazine | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0013-0102 | Azulfidine | Sulfasalazine | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0013-0102 | Azulfidine | Sulfasalazine | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0013-0102 | Azulfidine | Sulfasalazine | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0013-0102 | Azulfidine | Sulfasalazine | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0013-0102 | Azulfidine | Sulfasalazine | Pharmacia & Upjohn Company LLC | NDA | Current |
| 43353-495 | Sulfasalazine | Sulfasalazine | Aphena Pharma Solutions - Tennessee, LLC | NDA AUTHORIZED GENERIC | Current |
| 43353-495 | Sulfasalazine | Sulfasalazine | Aphena Pharma Solutions - Tennessee, LLC | NDA AUTHORIZED GENERIC | Current |
| 50090-0086 | Sulfasalazine | Sulfasalazine | A-S Medication Solutions | NDA AUTHORIZED | Current |
| 50090-0086 | Sulfasalazine | Sulfasalazine | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-0086 | Sulfasalazine | Sulfasalazine | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-0086 | Sulfasalazine | Sulfasalazine | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 59762-0104 | Sulfasalazine | Sulfasalazine | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0104 | Sulfasalazine | Sulfasalazine | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0104 | Sulfasalazine | Sulfasalazine | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0104 | Sulfasalazine | Sulfasalazine | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0104 | Sulfasalazine | Sulfasalazine | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0104 | Sulfasalazine | Sulfasalazine | Greenstone LLC | NDA AUTHORIZED | Current |
| 59762-0104 | Sulfasalazine | Sulfasalazine | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0104 | Sulfasalazine | Sulfasalazine | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0104 | Sulfasalazine | Sulfasalazine | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0104 | Sulfasalazine | Sulfasalazine | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5000 | Sulfasalazine | Sulfasalazine | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5000 | Sulfasalazine | Sulfasalazine | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5000 | Sulfasalazine | Sulfasalazine | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5000 | Sulfasalazine | Sulfasalazine | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5000 | Sulfasalazine | Sulfasalazine | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5000 | Sulfasalazine | Sulfasalazine | Greenstone LLC | NDA AUTHORIZED | Current |
| 59762-5000 | Sulfasalazine | Sulfasalazine | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5000 | Sulfasalazine | Sulfasalazine | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5000 | Sulfasalazine | Sulfasalazine | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 70518-1829 | Sulfasalazine | Sulfasalazine | REMEDYREPACK INC. | NDA AUTHORIZED GENERIC | Current |
| 70518-1829 | Sulfasalazine | Sulfasalazine | REMEDYREPACK INC. | NDA AUTHORIZED GENERIC | Current |
| 70518-1829 | Sulfasalazine | Sulfasalazine | REMEDYREPACK INC. | NDA AUTHORIZED GENERIC | Current |
| 70518-1829 | Sulfasalazine | Sulfasalazine | REMEDYREPACK INC. | NDA AUTHORIZED GENERIC | Current |
| 70518-1829 | Sulfasalazine | Sulfasalazine | REMEDYREPACK INC. | NDA AUTHORIZED GENERIC | Current |
| 70518-1829 | Sulfasalazine | Sulfasalazine | REMEDYREPACK INC. | NDA AUTHORIZED GENERIC | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 72662 | SUPPL | 2022-11-21 |
| 72633 | SUPPL | 2022-11-17 |
| 69210 | SUPPL | 2021-11-02 |
| 69203 | SUPPL | 2021-11-02 |
| 65956 | SUPPL | 2021-01-22 |
| 65944 | SUPPL | 2021-01-21 |
| 86 | SUPPL | 2014-03-06 |
| 10689 | SUPPL | 2014-03-05 |
| 32949 | SUPPL | 2013-07-23 |
| 34 | SUPPL | 2013-07-22 |
| 85 | SUPPL | 2012-12-18 |
| 32948 | SUPPL | 2012-12-13 |
| 32947 | SUPPL | 2009-10-21 |
| 84 | SUPPL | 2004-05-27 |
| 83 | SUPPL | 2004-05-27 |
| 32946 | SUPPL | 2003-05-07 |