acrivastine / Pseudoephedrine Oral Capsule
- Brand(s)
- Semprex-D
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Actient Pharmaceuticals, Llc (2015-05-05)
- Oldest Current Product
- 2012-01-26
- License(s)
- NDA
- RxNORM
- ORAL CAPSULE\ACRIVASTINE:PSEUDOEPHEDRINE
- FDAOB
- ORAL\CAPSULE\ACRIVASTINE: PSEUDOEPHEDRINE HYDROCHLORIDE
- SPL Active
- ORAL\CAPSULE\ACRIVASTINE: PSEUDOEPHEDRINE HYDROCHLORIDE
- SPL Moiety
- ORAL\CAPSULE\ACRIVASTINE: PSEUDOEPHEDRINE
product(s) by strength(s)
acrivastine 8 mg / pseudoephedrine hydrochloride 60 mg oral capsule
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|
| 1 | 522440404 | Semprex-D | NDA | Actient Pharmaceuticals, Llc | 2012-01-26 | ACRIVASTINE, PSEUDOEPHEDRINE HYDROCHLORIDE | ORAL | CAPSULE | NDA019806 | d86c6a13-9e5f-43c2-92f5-c7ed7bfcedfc |
| # | id | title | applicant | approved | approved drug |
|---|
| 1 | NDA019806 | SEMPREX-D | AUXILIUM PHARMACEUTICALS LLC | 1994-03-25 | NDA019806_001 |
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|
| 1 | NDA019806_001 | RX | PSEUDOEPHEDRINE HYDROCHLORIDE (60MG), ACRIVASTINE (8MG) | ORAL | CAPSULE | True | 1994-03-25 | SEMPREX-D |
| # | id | title | category | type | labeler | last update | version | product(s) |
|---|
| 1 | d86c6a13-9e5f-43c2-92f5-c7ed7bfcedfc (view SPL) | Semprex-D Capsules(acrivastine and pseudoephedrine hydrochloride) | prescription | Human Prescription | Actient Pharmaceuticals, Llc | 2015-05-05 | 4 | 522440404 |