Application 210729
- Type
- ANDA
- Sponsor
- ORIENT PHARMA CO LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 125MG BASE | No | No |
| 002 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 250MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0121-0867 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | PAI Holdings, LLC | ANDA | Current |
| 0121-0867 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Pharmaceutical Associates, Inc. | ANDA | Current |
| 0121-0867 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Pharmaceutical Associates, Inc. | ANDA | Current |
| 0121-0867 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Pharmaceutical Associates, Inc. | ANDA | Current |
| 0121-0867 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Pharmaceutical Associates, Inc. | ANDA | Current |
| 0121-0867 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Pharmaceutical Associates, Inc. | ANDA | Current |
| 0121-0867 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Pharmaceutical Associates, Inc. | ANDA | Current |
| 0121-0867 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Pharmaceutical Associates, Inc. | ANDA | Current |
| 0121-0867 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Pharmaceutical Associates, Inc. | ANDA | Current |
| 0121-0867 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | PAI Holdings, LLC | ANDA | Current |
| 0121-0890 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Pharmaceutical Associates, Inc. | ANDA | Current |
| 0121-0890 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Pharmaceutical Associates, Inc. | ANDA | Current |
| 0121-0890 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Pharmaceutical Associates, Inc. | ANDA | Current |
| 0121-0890 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Pharmaceutical Associates, Inc. | ANDA | Current |
| 0121-0890 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Pharmaceutical Associates, Inc. | ANDA | Current |
| 0121-0890 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Pharmaceutical Associates, Inc. | ANDA | Current |
| 0121-0890 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Pharmaceutical Associates, Inc. | ANDA | Current |
| 0121-0890 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Pharmaceutical Associates, Inc. | ANDA | Current |
| 0121-0890 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | PAI Holdings, LLC | ANDA | Current |
| 0121-0890 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | PAI Holdings, LLC | ANDA | Current |
| 76333-264 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Orient Pharma Co.,Ltd | ANDA | Current |
| 76333-264 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Orient Pharma Co.,Ltd | ANDA | Current |
| 76333-264 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Orient Pharma Co.,Ltd Yunlin Plant | ANDA | Current |
| 76333-264 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Orient Pharma Co.,Ltd Yunlin Plant | ANDA | Current |
| 76333-265 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Orient Pharma Co.,Ltd | ANDA | Current |
| 76333-265 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Orient Pharma Co.,Ltd | ANDA | Current |
| 76333-265 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Orient Pharma Co.,Ltd Yunlin Plant | ANDA | Current |
| 76333-265 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Orient Pharma Co.,Ltd Yunlin Plant | ANDA | Current |