Application 215534
- Type
- ANDA
- Sponsor
- ANNORA PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SAPROPTERIN DIHYDROCHLORIDE | SAPROPTERIN DIHYDROCHLORIDE | TABLET;ORAL | 100MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 31722-045 | sapropterin dihydrochloride | sapropterin dihydrochloride | Camber Pharmaceuticals, Inc. | ANDA | Current |