Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075060
Company: XTTRIUM LABS INC
Company: XTTRIUM LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 50MG/5ML | SYRUP;ORAL | Discontinued | 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 |
|---|---|---|---|---|---|---|---|
| 12/24/1998 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75060ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/31/2011 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/14/2007 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 01/12/2007 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 08/15/2001 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |