Application 074819
- Type
- ANDA
- Sponsor
- OXFORD PHARMS
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ETODOLAC | ETODOLAC | TABLET;ORAL | 400MG | No | No |
| 002 | ETODOLAC | ETODOLAC | TABLET;ORAL | 500MG | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 67296-0595 | ETODOLAC | etodolac | RedPharm Drug Inc. | ANDA | Current |
Documents
| Document | Submission type | Date |
|---|---|---|
| 53916 | ORIG | 2018-05-01 |