Application 205135
- Type
- ANDA
- Sponsor
- SUN PHARM INDS INC
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 57664-606 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-607 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-608 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-609 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |