Application 206323
- Type
- NDA
- Sponsor
- MAINPOINTE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TUXARIN ER | CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE | TABLET, EXTENDED RELEASE;ORAL | 8MG;54.3MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0722-7184 | CODEINE AND CHLORPHENIRAMINE MALEATE ER | CODEINE AND CHLORPHENIRAMINE MALEATE ER | Nexgen Pharma, Inc. | NDA | Current |
| 71269-040 | Tuxarin | codeine phosphate and chlorpheniramine maleate | Mainpointe Pharmaceuticals | NDA | Current |
| 71269-040 | Tuxarin | codeine phosphate and chlorpheniramine maleate | Mainpointe Pharmaceuticals | NDA | Current |
| 71269-040 | Tuxarin | codeine phosphate and chlorpheniramine maleate | Mainpointe Pharmaceuticals | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 77096 | SUPPL | 2023-12-21 |
| 77095 | SUPPL | 2023-12-21 |
| 77015 | SUPPL | 2023-12-19 |
| 54833 | SUPPL | 2018-07-06 |
| 54806 | SUPPL | 2018-07-06 |
| 54768 | SUPPL | 2018-07-05 |
| 49637 | SUPPL | 2017-08-31 |
| 49605 | SUPPL | 2017-08-30 |
| 46891 | SUPPL | 2017-01-18 |
| 46865 | SUPPL | 2017-01-13 |
| 45571 | SUPPL | 2016-10-21 |
| 43517 | ORIG | 2016-05-25 |
| 10561 | ORIG | 2015-06-26 |
| 40538 | ORIG | 2015-06-24 |