Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200043
Company: MYLAN PHARMS INC
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 | Url |
|---|---|---|---|---|---|---|---|
| 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. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200043s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/13/2019 | SUPPL-6 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label is not available on this site. |
||
| 01/20/2016 | SUPPL-4 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/20/2016 | SUPPL-1 | Labeling-Medication Guide |
Label is not available on this site. |
ARMODAFINIL
TABLET;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ARMODAFINIL | ARMODAFINIL | 50MG | TABLET;ORAL | Prescription | No | AB | 206069 | AUROBINDO PHARMA LTD |
| ARMODAFINIL | ARMODAFINIL | 50MG | TABLET;ORAL | Prescription | No | AB | 200751 | LUPIN LTD |
| ARMODAFINIL | ARMODAFINIL | 50MG | TABLET;ORAL | Prescription | No | AB | 200043 | MYLAN PHARMS INC |
| ARMODAFINIL | ARMODAFINIL | 50MG | TABLET;ORAL | Prescription | No | AB | 202768 | NATCO PHARMA LTD |
| NUVIGIL | ARMODAFINIL | 50MG | TABLET;ORAL | Prescription | Yes | AB | 021875 | CEPHALON |
TABLET;ORAL; 150MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ARMODAFINIL | ARMODAFINIL | 150MG | TABLET;ORAL | Prescription | No | AB | 206069 | AUROBINDO PHARMA LTD |
| ARMODAFINIL | ARMODAFINIL | 150MG | TABLET;ORAL | Prescription | No | AB | 200751 | LUPIN LTD |
| ARMODAFINIL | ARMODAFINIL | 150MG | TABLET;ORAL | Prescription | No | AB | 200043 | MYLAN PHARMS INC |
| ARMODAFINIL | ARMODAFINIL | 150MG | TABLET;ORAL | Prescription | No | AB | 202768 | NATCO PHARMA LTD |
| NUVIGIL | ARMODAFINIL | 150MG | TABLET;ORAL | Prescription | Yes | AB | 021875 | CEPHALON |
TABLET;ORAL; 250MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ARMODAFINIL | ARMODAFINIL | 250MG | TABLET;ORAL | Prescription | No | AB | 206069 | AUROBINDO PHARMA LTD |
| ARMODAFINIL | ARMODAFINIL | 250MG | TABLET;ORAL | Prescription | No | AB | 200751 | LUPIN LTD |
| ARMODAFINIL | ARMODAFINIL | 250MG | TABLET;ORAL | Prescription | No | AB | 200043 | MYLAN PHARMS INC |
| ARMODAFINIL | ARMODAFINIL | 250MG | TABLET;ORAL | Prescription | No | AB | 202768 | NATCO PHARMA LTD |
| NUVIGIL | ARMODAFINIL | 250MG | TABLET;ORAL | Prescription | Yes | AB | 021875 | CEPHALON |
TABLET;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ARMODAFINIL | ARMODAFINIL | 100MG | TABLET;ORAL | Prescription | No | AB | 200043 | MYLAN PHARMS INC |
| ARMODAFINIL | ARMODAFINIL | 100MG | TABLET;ORAL | Prescription | No | AB | 202768 | NATCO PHARMA LTD |
TABLET;ORAL; 200MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ARMODAFINIL | ARMODAFINIL | 200MG | TABLET;ORAL | Prescription | No | AB | 206069 | AUROBINDO PHARMA LTD |
| ARMODAFINIL | ARMODAFINIL | 200MG | TABLET;ORAL | Prescription | No | AB | 200751 | LUPIN LTD |
| ARMODAFINIL | ARMODAFINIL | 200MG | TABLET;ORAL | Prescription | No | AB | 200043 | MYLAN PHARMS INC |
| ARMODAFINIL | ARMODAFINIL | 200MG | TABLET;ORAL | Prescription | No | AB | 202768 | NATCO PHARMA LTD |
| NUVIGIL | ARMODAFINIL | 200MG | TABLET;ORAL | Prescription | Yes | AB | 021875 | CEPHALON |