FdaApplication
ANDA 201633
Identifiers
- fda_app_no: ANDA201633
Properties
| Property | Value |
|---|---|
| applicant_name | SUN PHARMACEUTICAL INDUSTRIES LTD |
| application_type | ANDA |
| approval_date | 2016-08-05 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 2MG BASE;EQ 0.5MG BASE | TABLET;SUBLINGUAL |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 8MG BASE;EQ 2MG BASE | TABLET;SUBLINGUAL |
2 products