New Drug Application (NDA): 021875
Company: CEPHALON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|
| NUVIGIL | ARMODAFINIL | 50MG | TABLET;ORAL | Prescription | AB | Yes | No |
| NUVIGIL | ARMODAFINIL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| NUVIGIL | ARMODAFINIL | 150MG | TABLET;ORAL | Prescription | AB | Yes | No |
| NUVIGIL | ARMODAFINIL | 250MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| NUVIGIL | ARMODAFINIL | 200MG | TABLET;ORAL | Prescription | AB | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes |
|---|
| 06/15/2007 | ORIG-1 | Approval | Type 5 – New Formulation or New Manufacturer | STANDARD | Label (PDF)
Letter (PDF)
Review |
Abbreviated New Drug Application (ANDA): 200043
Company: MYLAN PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|
| ARMODAFINIL | ARMODAFINIL | 50MG | TABLET;ORAL | Prescription | AB | No | No |
| ARMODAFINIL | ARMODAFINIL | 150MG | TABLET;ORAL | Prescription | AB | No | No |
| ARMODAFINIL | ARMODAFINIL | 250MG | TABLET;ORAL | Prescription | AB | No | No |
| ARMODAFINIL | ARMODAFINIL | 100MG | TABLET;ORAL | Prescription | AB | No | No |
| ARMODAFINIL | ARMODAFINIL | 200MG | TABLET;ORAL | Prescription | AB | 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 |
|---|
| 05/09/2019 | ORIG-2 | Approval | Not Applicable | | | Label is not available on this site. |
| 06/01/2012 | ORIG-1 | Approval | Not Applicable | | Letter (PDF) | Label is not available on this site. |
Abbreviated New Drug Application (ANDA): 200152
Company: TEVA PHARMS USA 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 | None (Tentative Approval) | None | No | No |
| ARMODAFINIL | ARMODAFINIL | 150MG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
| ARMODAFINIL | ARMODAFINIL | 200MG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
| ARMODAFINIL | ARMODAFINIL | 250MG | 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 |
|---|
| 09/24/2014 | ORIG-1 | Tentative Approval | | | | Label is not available on this site. |
Abbreviated New Drug Application (ANDA): 200156
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 |
|---|
| 08/29/2012 | ORIG-2 | Tentative Approval | Not Applicable | | | Label is not available on this site. |
| 08/29/2012 | ORIG-1 | Approval | Not Applicable | | Letter (PDF) | Label is not available on this site. |
Abbreviated New Drug Application (ANDA): 200751
Company: LUPIN LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|
| ARMODAFINIL | ARMODAFINIL | 50MG | TABLET;ORAL | Prescription | AB | No | No |
| ARMODAFINIL | ARMODAFINIL | 100MG | TABLET; ORAL | None (Tentative Approval) | None | No | No |
| ARMODAFINIL | ARMODAFINIL | 150MG | TABLET;ORAL | Prescription | AB | No | No |
| ARMODAFINIL | ARMODAFINIL | 200MG | TABLET;ORAL | Prescription | AB | No | No |
| ARMODAFINIL | ARMODAFINIL | 250MG | TABLET;ORAL | Prescription | AB | 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 |
|---|
| 11/28/2016 | ORIG-2 | Tentative Approval | Not Applicable | | | Label is not available on this site. |
| 11/28/2016 | ORIG-1 | Approval | Not Applicable | | | Label is not available on this site. |
Abbreviated New Drug Application (ANDA): 201514
Company: COREPHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|
| ARMODAFINIL | ARMODAFINIL | 50MG | TABLET;ORAL | Discontinued | None | No | No |
| ARMODAFINIL | ARMODAFINIL | 150MG | TABLET;ORAL | Discontinued | None | No | No |
| ARMODAFINIL | ARMODAFINIL | 250MG | TABLET;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 |
|---|
| 03/25/2019 | ORIG-1 | Approval | Not Applicable | | | Label is not available on this site. |
Abbreviated New Drug Application (ANDA): 202768
Company: NATCO PHARMA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|
| ARMODAFINIL | ARMODAFINIL | 50MG | TABLET;ORAL | Prescription | AB | No | No |
| ARMODAFINIL | ARMODAFINIL | 150MG | TABLET;ORAL | Prescription | AB | No | No |
| ARMODAFINIL | ARMODAFINIL | 250MG | TABLET;ORAL | Prescription | AB | No | No |
| ARMODAFINIL | ARMODAFINIL | 100MG | TABLET;ORAL | Prescription | AB | No | No |
| ARMODAFINIL | ARMODAFINIL | 200MG | TABLET;ORAL | Prescription | AB | 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 |
|---|
| 11/28/2016 | ORIG-1 | Approval | | | Letter (PDF) | Label is not available on this site. |
Abbreviated New Drug Application (ANDA): 206069
Company: AUROBINDO PHARMA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|
| ARMODAFINIL | ARMODAFINIL | 50MG | TABLET;ORAL | Prescription | AB | No | No |
| ARMODAFINIL | ARMODAFINIL | 150MG | TABLET;ORAL | Prescription | AB | No | No |
| ARMODAFINIL | ARMODAFINIL | 250MG | TABLET;ORAL | Prescription | AB | No | No |
| ARMODAFINIL | ARMODAFINIL | 200MG | TABLET;ORAL | Prescription | AB | 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 |
|---|
| 03/06/2018 | ORIG-1 | Approval | | STANDARD | | Label is not available on this site. |