Application 208043
- Type
- ANDA
- Sponsor
- ACTAVIS LABS FL INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | NALTREXONE HYDROCHLORIDE; BUPROPION HYDROCHLORIDE | NALTREXONE HYDROCHLORIDE;BUPROPION HYDROCHLORIDE | TABLET, EXTENDED RELEASE; ORAL | 8MG/90MG | No | No |
Source provenance: Browse the complete Orange Book source catalog.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 72951 | ORIG | 2022-12-20 |