Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207196
Company: APPCO
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 | Url |
---|---|---|---|---|---|---|---|
08/16/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/28/2021 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
MODAFINIL
TABLET;ORAL; 100MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MODAFINIL | MODAFINIL | 100MG | TABLET;ORAL | Prescription | No | AB | 202700 | ALEMBIC |
MODAFINIL | MODAFINIL | 100MG | TABLET;ORAL | Prescription | No | AB | 077667 | APOTEX |
MODAFINIL | MODAFINIL | 100MG | TABLET;ORAL | Prescription | No | AB | 207196 | APPCO |
MODAFINIL | MODAFINIL | 100MG | TABLET;ORAL | Prescription | No | AB | 202566 | AUROBINDO PHARMA LTD |
MODAFINIL | MODAFINIL | 100MG | TABLET;ORAL | Prescription | No | AB | 209966 | CADILA |
MODAFINIL | MODAFINIL | 100MG | TABLET;ORAL | Prescription | No | AB | 078963 | ORBION PHARMS |
MODAFINIL | MODAFINIL | 100MG | TABLET;ORAL | Prescription | No | AB | 076715 | WATSON LABS INC |
PROVIGIL | MODAFINIL | 100MG | TABLET;ORAL | Prescription | Yes | AB | 020717 | CEPHALON |
TABLET;ORAL; 200MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MODAFINIL | MODAFINIL | 200MG | TABLET;ORAL | Prescription | No | AB | 202700 | ALEMBIC |
MODAFINIL | MODAFINIL | 200MG | TABLET;ORAL | Prescription | No | AB | 077667 | APOTEX |
MODAFINIL | MODAFINIL | 200MG | TABLET;ORAL | Prescription | No | AB | 207196 | APPCO |
MODAFINIL | MODAFINIL | 200MG | TABLET;ORAL | Prescription | No | AB | 202566 | AUROBINDO PHARMA LTD |
MODAFINIL | MODAFINIL | 200MG | TABLET;ORAL | Prescription | No | AB | 209966 | CADILA |
MODAFINIL | MODAFINIL | 200MG | TABLET;ORAL | Prescription | No | AB | 078963 | ORBION PHARMS |
MODAFINIL | MODAFINIL | 200MG | TABLET;ORAL | Prescription | No | AB | 076715 | WATSON LABS INC |
PROVIGIL | MODAFINIL | 200MG | TABLET;ORAL | Prescription | Yes | AB | 020717 | CEPHALON |