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Application 212244
- Type
- ANDA
- Sponsor
- ALKEM LABS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 20MG | No | No |
| 002 | LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 40MG | No | No |
| 003 | LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 60MG | No | No |
| 004 | LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 80MG | No | No |
| 005 | LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 120MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 67877-638 | lurasidone hydrochloride | lurasidone hydrochloride | Ascend Laboratories, LLC | ANDA | Current |
| 67877-639 | lurasidone hydrochloride | lurasidone hydrochloride | Ascend Laboratories, LLC | ANDA | Current |
| 67877-640 | lurasidone hydrochloride | lurasidone hydrochloride | Ascend Laboratories, LLC | ANDA | Current |
| 67877-641 | lurasidone hydrochloride | lurasidone hydrochloride | Ascend Laboratories, LLC | ANDA | Current |
| 67877-642 | lurasidone hydrochloride | lurasidone hydrochloride | Ascend Laboratories, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 63034 | ORIG | 2020-05-15 |