Application 207210
- Type
- ANDA
- Sponsor
- MACLEODS PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ENTACAPONE | ENTACAPONE | TABLET;ORAL | 200MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0615-8298 | Entacapone | Entacapone | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 33342-260 | Entacapone | Entacapone | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-260 | Entacapone | Entacapone | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-260 | Entacapone | Entacapone | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-260 | Entacapone | Entacapone | Macleods Pharmaceuticals Limited | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 48685 | ORIG | 2017-06-09 |