Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091211
Company: GLENMARK GENERICS
Company: GLENMARK GENERICS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | ATOVAQUONE; PROGUANIL HYDROCHLORIDE | 250MG;100MG | TABLET;ORAL | Prescription | AB | No | No |
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | ATOVAQUONE; PROGUANIL HYDROCHLORIDE | 62.5MG;25MG | 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 |
---|---|---|---|---|---|---|---|
01/12/2011 | 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 |
---|---|---|---|---|---|
11/22/2019 | SUPPL-9 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
06/04/2014 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE
TABLET;ORAL; 250MG;100MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | ATOVAQUONE; PROGUANIL HYDROCHLORIDE | 250MG;100MG | TABLET;ORAL | Prescription | No | AB | 091211 | GLENMARK GENERICS |
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | ATOVAQUONE; PROGUANIL HYDROCHLORIDE | 250MG;100MG | TABLET;ORAL | Prescription | No | AB | 202362 | MYLAN |
MALARONE | ATOVAQUONE; PROGUANIL HYDROCHLORIDE | 250MG;100MG | TABLET;ORAL | Prescription | Yes | AB | 021078 | GLAXOSMITHKLINE |
TABLET;ORAL; 62.5MG;25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | ATOVAQUONE; PROGUANIL HYDROCHLORIDE | 62.5MG;25MG | TABLET;ORAL | Prescription | No | AB | 091211 | GLENMARK GENERICS |
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | ATOVAQUONE; PROGUANIL HYDROCHLORIDE | 62.5MG;25MG | TABLET;ORAL | Prescription | No | AB | 202362 | MYLAN |
MALARONE PEDIATRIC | ATOVAQUONE; PROGUANIL HYDROCHLORIDE | 62.5MG;25MG | TABLET;ORAL | Prescription | Yes | AB | 021078 | GLAXOSMITHKLINE |