Application 214737
- Type
- ANDA
- Sponsor
- SUN PHARM INDUSTRIES
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | TABLET;SUBLINGUAL | EQ 1.4MG BASE;EQ 0.36MG BASE | No | No |
| 002 | 0 | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | TABLET;SUBLINGUAL | EQ 5.7MG BASE;EQ 1.4MG BASE | No | No |
| 003 | 0 | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | TABLET;SUBLINGUAL | EQ 8.6MG BASE;EQ 2.1MG BASE | No | No |
| 004 | 0 | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | TABLET;SUBLINGUAL | EQ 11.4MG BASE;EQ 2.9MG BASE | No | No |
| 005 | 0 | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | TABLET;SUBLINGUAL | EQ 2.9MG BASE;EQ 0.71MG BASE | No | No |
| 006 | 0 | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | TABLET;SUBLINGUAL | EQ 0.7MG BASE;EQ 0.18MG BASE | No | No |