FdaApplication
ANDA 213485
Identifiers
- fda_app_no: ANDA213485
Properties
| Property | Value |
|---|---|
| applicant_name | CSPC OUYI PHARMACEUTICAL CO LTD |
| application_type | ANDA |
| approval_date | 2021-02-16 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 12.5MG BASE | TABLET, EXTENDED RELEASE;ORAL |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 37.5MG BASE | TABLET, EXTENDED RELEASE;ORAL |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 25MG BASE | TABLET, EXTENDED RELEASE;ORAL |
3 products