FdaApplication
ANDA 214930
Identifiers
- fda_app_no: ANDA214930
Properties
| Property | Value |
|---|---|
| applicant_name | ALKEM LABORATORIES LTD |
| application_type | ANDA |
| approval_date | 2021-06-15 |
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