Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214897
Company: ZYDUS PHARMS USA INC
Company: ZYDUS PHARMS USA INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMANTADINE | AMANTADINE | 65.5MG | CAPSULE, EXTENDED RELEASE;ORAL | None (Tentative Approval) | None | No | No |
| AMANTADINE | AMANTADINE | 137MG | CAPSULE, EXTENDED RELEASE;ORAL | None (Tentative Approval) | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 09/29/2022 | ORIG-1 | Tentative Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214897Orig1s000TAltr.pdf |