Application 207207
- Type
- ANDA
- Sponsor
- PAR PHARM INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SAPROPTERIN DIHYDROCHLORIDE | SAPROPTERIN DIHYDROCHLORIDE | POWDER;ORAL | 100MG/PACKET | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 49884-948 | SAPROPTERIN DIHYDROCHLORIDE | SAPROPTERIN DIHYDROCHLORIDE | Par Pharmaceutical, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 60145 | ORIG | 2019-09-27 |