Application 213612
- Type
- ANDA
- Sponsor
- SINOTHERAPEUTICS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 12.5MG BASE | No | No |
| 002 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 25MG BASE | No | No |
| 003 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 37.5MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 69986-011 | paroxetine hydrochloride | paroxetine hydrochloride | Sinotherapeutics Inc. | ANDA | Current |
| 69986-012 | paroxetine hydrochloride | paroxetine hydrochloride | Sinotherapeutics Inc. | ANDA | Current |