Application 204383
- Type
- ANDA
- Sponsor
- ACTAVIS LABS UT INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | FILM;BUCCAL, SUBLINGUAL | EQ 8MG BASE;EQ 2MG BASE | 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 |
|---|
| 54286 | ORIG | 2018-05-22 |