Application 210704
- Type
- ANDA
- Sponsor
- BAYSHORE PHARMS LLC
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 76385-118 | Etodolac | Etodolac | Bayshore Pharmaceuticals, LLC | ANDA | Current |
| 76385-118 | Etodolac | Etodolac | Bayshore Pharmaceuticals, LLC | ANDA | Current |
| 76385-119 | Etodolac | Etodolac | Bayshore Pharmaceuticals, LLC | ANDA | Current |
| 76385-119 | Etodolac | Etodolac | Bayshore Pharmaceuticals, LLC | ANDA | Current |