Application 213473
- Type
- ANDA
- Sponsor
- DR REDDYS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 18MG | No | No |
| 002 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 27MG | No | No |
| 003 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 36MG | No | No |
| 004 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 54MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 43598-438 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Dr.Reddys Laboratories Inc | ANDA | Current |
| 43598-439 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Dr.Reddys Laboratories Inc | ANDA | Current |
| 43598-440 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Dr.Reddys Laboratories Inc | ANDA | Current |
| 43598-441 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Dr.Reddys Laboratories Inc | ANDA | Current |