Application 209452
- Type
- ANDA
- Sponsor
- DR REDDYS LABS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SAPROPTERIN DIHYDROCHLORIDE | SAPROPTERIN DIHYDROCHLORIDE | POWDER FOR ORAL SOLUTION | 100MG/PACKET | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 43598-097 | JAVYGTOR | Sapropterin Dihydrochloride | Dr. Reddys Laboratories Inc | ANDA | Current |
| 43598-477 | Sapropterin Dihydrochloride | Sapropterin Dihydrochloride | Dr. Reddys Laboratories Inc | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 50991 | ORIG | 2020-03-17 |