Application 008085
- Type
- NDA
- Sponsor
- DAVA PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | METHOTREXATE SODIUM | METHOTREXATE SODIUM | TABLET;ORAL | EQ 2.5MG BASE | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42254-110 | METHOTREXATE | METHOTREXATE | Rebel Distributors Corp | NDA | Current |
| 50090-0294 | METHOTREXATE | METHOTREXATE | A-S Medication Solutions | NDA | Current |
| 50090-0294 | METHOTREXATE | METHOTREXATE | A-S Medication Solutions | NDA | Current |
| 66336-338 | METHOTREXATE | METHOTREXATE | Dispensing Solutions, Inc. | NDA | Current |
| 67253-320 | METHOTREXATE | METHOTREXATE | Par Pharmaceutical | NDA | Current |
| 67253-320 | METHOTREXATE | METHOTREXATE | Par Pharmaceutical, Inc. | NDA | Current |
| 70518-0223 | METHOTREXATE | METHOTREXATE | REMEDYREPACK INC. | NDA | Current |
| 70518-0223 | METHOTREXATE | METHOTREXATE | REMEDYREPACK INC. | NDA | Current |
| 70518-0223 | METHOTREXATE | METHOTREXATE | REMEDYREPACK INC. | NDA | Current |
| 75840-111 | METHOTREXATE SODIUM | METHOTREXATE SODIUM | GenPak Solutions LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 62824 | SUPPL | 2020-05-05 |
| 62817 | SUPPL | 2020-05-05 |
| 53061 | SUPPL | 2018-03-20 |
| 53042 | SUPPL | 2018-03-16 |
| 32958 | SUPPL | 2016-02-18 |
| 142 | SUPPL | 2016-02-01 |
| 141 | SUPPL | 2006-06-02 |
| 32957 | SUPPL | 2003-11-05 |
| 32956 | SUPPL | 2003-11-05 |
| 91 | SUPPL | 2003-11-05 |
| 89 | SUPPL | 2003-11-05 |
| 140 | SUPPL | 2002-02-20 |
| 90 | SUPPL | 2002-02-20 |