Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200156
Company: WATSON LABS INC
Company: WATSON LABS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ARMODAFINIL | ARMODAFINIL | 50MG | TABLET; ORAL | None (Tentative Approval) | None | No | No |
ARMODAFINIL | ARMODAFINIL | 100MG | TABLET;ORAL | Discontinued | None | No | No |
ARMODAFINIL | ARMODAFINIL | 150MG | TABLET; ORAL | None (Tentative Approval) | None | No | No |
ARMODAFINIL | ARMODAFINIL | 200MG | TABLET;ORAL | Discontinued | None | No | No |
ARMODAFINIL | ARMODAFINIL | 2500MG | TABLET; 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 |
---|---|---|---|---|---|---|---|
08/29/2012 | ORIG-2 | Tentative Approval | Not Applicable |
Label is not available on this site. |
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08/29/2012 | ORIG-1 | Approval | Not Applicable |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200156Orig1s000.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/25/2017 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |