Application 216462
- Type
- ANDA
- Sponsor
- GLENMARK PHARMS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SODIUM PHENYLBUTYRATE | SODIUM PHENYLBUTYRATE | TABLET;ORAL | 500MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68462-853 | sodium phenylbutyrate | sodium phenylbutyrate | GLENMARK PHARMACEUTICALS INC., USA | ANDA | Current |