Application 062982
- Type
- ANDA
- Sponsor
- DAVA PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMPICILLIN TRIHYDRATE | AMPICILLIN/AMPICILLIN TRIHYDRATE | FOR SUSPENSION;ORAL | EQ 125MG BASE/5ML | No | No |
| 002 | AMPICILLIN TRIHYDRATE | AMPICILLIN/AMPICILLIN TRIHYDRATE | FOR SUSPENSION;ORAL | EQ 250MG BASE/5ML | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 67253-182 | Ampicillin | Ampicillin | Par Pharmaceutical | ANDA | Current |
| 67253-182 | Ampicillin | Ampicillin | Par Pharmaceutical | ANDA | Current |
| 67253-183 | Ampicillin | Ampicillin | Par Pharmaceutical | ANDA | Current |
| 67253-183 | Ampicillin | Ampicillin | Par Pharmaceutical | ANDA | Current |