Application 073585
- Type
- ANDA
- Sponsor
- MCNEIL CONS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SUDAFED 12 HOUR | PSEUDOEPHEDRINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 120MG | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50090-1106 | Sudafed 12 Hour | Pseudoephedrine hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-1106 | Sudafed 12 Hour | Pseudoephedrine hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50580-670 | Sudafed 12 Hour | Pseudoephedrine hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 42832 | ORIG | 2012-03-27 |