New Drug Application (NDA): 020717
Company: CEPHALON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|
| PROVIGIL | MODAFINIL | 100MG | TABLET;ORAL | Prescription | AB | Yes | No |
| PROVIGIL | MODAFINIL | 200MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes |
|---|
| 12/24/1998 | ORIG-1 | Approval | Type 1 – New Molecular Entity | STANDARD; Orphan | Label (PDF)
Letter (PDF)
Review |
Abbreviated New Drug Application (ANDA): 076594
Company: NATCO PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|
| MODAFINIL | MODAFINIL | 100MG | TABLET;ORAL | Discontinued | None | No | No |
| MODAFINIL | MODAFINIL | 200MG | 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 |
|---|
| 07/16/2012 | ORIG-1 | Approval | | | | Label is not available on this site. |
Abbreviated New Drug Application (ANDA): 076596
Company: TEVA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|
| MODAFINIL | MODAFINIL | 100MG | TABLET; ORAL | None (Tentative Approval) | None | No | No |
| MODAFINIL | MODAFINIL | 200MG | 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 |
|---|
| 12/16/2005 | ORIG-1 | Tentative Approval | | | | Label is not available on this site. |
Abbreviated New Drug Application (ANDA): 076597
Company: BARR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|
| MODAFINIL | MODAFINIL | 100MG | Tablet; Oral | None (Tentative Approval) | None | No | No |
| MODAFINIL | MODAFINIL | 200MG | 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 |
|---|
| 01/07/2004 | ORIG-1 | Tentative Approval | | | | Label is not available on this site. |
Abbreviated New Drug Application (ANDA): 076715
Company: WATSON LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|
| MODAFINIL | MODAFINIL | 100MG | TABLET;ORAL | Prescription | AB | No | No |
| MODAFINIL | MODAFINIL | 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 |
|---|
| 11/01/2012 | ORIG-1 | Approval | | | | Label is not available on this site. |
Abbreviated New Drug Application (ANDA): 076935
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|
| MODAFINIL | MODAFINIL | 100MG | TABLET; ORAL | None (Tentative Approval) | None | No | No |
| MODAFINIL | MODAFINIL | 200MG | 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 |
|---|
| 12/29/2006 | ORIG-1 | Tentative Approval | | | | Label is not available on this site. |
Abbreviated New Drug Application (ANDA): 077667
Company: APOTEX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|
| MODAFINIL | MODAFINIL | 100MG | TABLET;ORAL | Prescription | AB | No | No |
| MODAFINIL | MODAFINIL | 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 |
|---|
| 02/03/2014 | ORIG-1 | Approval | | | | Label is not available on this site. |
Abbreviated New Drug Application (ANDA): 077892
Company: CARACO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|
| MODAFINIL | MODAFINIL | 100MG | TABLET; ORAL | None (Tentative Approval) | None | No | No |
| MODAFINIL | MODAFINIL | 200MG | 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 |
|---|
| 07/18/2007 | ORIG-1 | Tentative Approval | | | | Label is not available on this site. |
Abbreviated New Drug Application (ANDA): 078963
Company: ORBION PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|
| MODAFINIL | MODAFINIL | 100MG | TABLET;ORAL | Prescription | AB | No | No |
| MODAFINIL | MODAFINIL | 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 |
|---|
| 09/26/2012 | ORIG-1 | Approval | | | | Label is not available on this site. |
Abbreviated New Drug Application (ANDA): 090543
Company: HIKMA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|
| MODAFINIL | MODAFINIL | 100MG | TABLET;ORAL | Discontinued | None | No | No |
| MODAFINIL | MODAFINIL | 200MG | 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 |
|---|
| 09/26/2012 | ORIG-1 | Approval | | | | Label is not available on this site. |
Abbreviated New Drug Application (ANDA): 202566
Company: AUROBINDO PHARMA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|
| MODAFINIL | MODAFINIL | 100MG | TABLET;ORAL | Prescription | AB | No | No |
| MODAFINIL | MODAFINIL | 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 |
|---|
| 09/27/2012 | ORIG-1 | Approval | | | | Label is not available on this site. |
Abbreviated New Drug Application (ANDA): 202700
Company: ALEMBIC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|
| MODAFINIL | MODAFINIL | 100MG | TABLET;ORAL | Prescription | AB | No | No |
| MODAFINIL | MODAFINIL | 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 |
|---|
| 10/18/2012 | ORIG-1 | Approval | | | | Label is not available on this site. |
Abbreviated New Drug Application (ANDA): 207196
Company: APPCO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|
| MODAFINIL | MODAFINIL | 100MG | TABLET;ORAL | Prescription | AB | No | No |
| MODAFINIL | MODAFINIL | 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 |
|---|
| 08/16/2017 | ORIG-1 | Approval | | STANDARD | | Label is not available on this site. |
Abbreviated New Drug Application (ANDA): 209966
Company: CADILA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|
| MODAFINIL | MODAFINIL | 100MG | TABLET;ORAL | Prescription | AB | No | No |
| MODAFINIL | MODAFINIL | 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 |
|---|
| 09/14/2017 | ORIG-1 | Approval | | STANDARD | | Label is not available on this site. |