Application 078194
- Type
- ANDA
- Sponsor
- SUN PHARM INDS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | TABLET;ORAL | EQ 10MG BASE | No | No |
| 002 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | TABLET;ORAL | EQ 20MG BASE | No | No |
| 003 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | TABLET;ORAL | EQ 30MG BASE | No | No |
| 004 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | TABLET;ORAL | EQ 40MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 57664-421 | Paroxetine | Paroxetine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-422 | Paroxetine | Paroxetine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-424 | Paroxetine | Paroxetine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-425 | Paroxetine | Paroxetine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 44377 | ORIG | 2007-07-05 |