Application 065194
- Type
- ANDA
- Sponsor
- EPIC PHARMA LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 150MG BASE | No | No |
| 002 | CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 300MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 67046-085 | Clindamycin Hydrochloride | Clindamycin Hydrochloride | Contract Pharmacy Services-PA | ANDA | Current |
| 69238-2121 | clindamycin hydrochloride | clindamycin hydrochloride | Amneal Pharmaceuticals NY LLC | ANDA | Current |