Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076523
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MEFLOQUINE HYDROCHLORIDE | MEFLOQUINE HYDROCHLORIDE | 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 | Url |
---|---|---|---|---|---|---|---|
10/01/2004 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/11/2016 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
07/26/2013 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076523s007lbl.pdf | |
08/15/2011 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
11/18/2009 | SUPPL-5 | Labeling-Medication Guide |
Label is not available on this site. |
||
10/20/2009 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
02/19/2009 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
09/18/2008 | SUPPL-2 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/26/2013 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076523s007lbl.pdf |
MEFLOQUINE HYDROCHLORIDE
TABLET;ORAL; 250MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MEFLOQUINE HYDROCHLORIDE | MEFLOQUINE HYDROCHLORIDE | 250MG | TABLET;ORAL | Prescription | No | AB | 076392 | BARR |
MEFLOQUINE HYDROCHLORIDE | MEFLOQUINE HYDROCHLORIDE | 250MG | TABLET;ORAL | Prescription | No | AB | 076523 | HIKMA |