Application 019806
- Type
- NDA
- Sponsor
- AUXILIUM PHARMS LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SEMPREX-D | ACRIVASTINE; PSEUDOEPHEDRINE HYDROCHLORIDE | CAPSULE;ORAL | 8MG;60MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 52244-404 | SEMPREX | acrivastine and pseudoephedrine hydrochloride | Endo Pharmaceuticals Inc. | NDA | Current |
| 52244-404 | SEMPREX | acrivastine and pseudoephedrine hydrochloride | Endo Pharmaceuticals, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 53654 | SUPPL | 2018-04-12 |
| 53649 | SUPPL | 2018-04-11 |
| 1629 | SUPPL | 2004-02-27 |