Details for New Drug Application (NDA): 021078
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NDA 021078 describes MALARONE PEDIATRIC, which is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from three suppliers. Additional details are available on the MALARONE PEDIATRIC profile page.
The generic ingredient in MALARONE PEDIATRIC is atovaquone; proguanil hydrochloride. There are sixteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the atovaquone; proguanil hydrochloride profile page.
The generic ingredient in MALARONE PEDIATRIC is atovaquone; proguanil hydrochloride. There are sixteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the atovaquone; proguanil hydrochloride profile page.
Summary for 021078
| Tradename: | MALARONE PEDIATRIC |
| Applicant: | Glaxosmithkline |
| Ingredient: | atovaquone; proguanil hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 021078
| Mechanism of Action | Dihydrofolate Reductase Inhibitors |
Suppliers and Packaging for NDA: 021078
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MALARONE | atovaquone; proguanil hydrochloride | TABLET;ORAL | 021078 | NDA | GlaxoSmithKline LLC | 0173-0675 | 0173-0675-01 | 100 TABLET, FILM COATED in 1 BOTTLE (0173-0675-01) |
| MALARONE | atovaquone; proguanil hydrochloride | TABLET;ORAL | 021078 | NDA | GlaxoSmithKline LLC | 0173-0675 | 0173-0675-02 | 24 TABLET, FILM COATED in 1 DOSE PACK (0173-0675-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG;100MG | ||||
| Approval Date: | Jul 14, 2000 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 62.5MG;25MG | ||||
| Approval Date: | Jul 14, 2000 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 021078
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxosmithkline | MALARONE | atovaquone; proguanil hydrochloride | TABLET;ORAL | 021078-001 | Jul 14, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline | MALARONE | atovaquone; proguanil hydrochloride | TABLET;ORAL | 021078-001 | Jul 14, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline | MALARONE PEDIATRIC | atovaquone; proguanil hydrochloride | TABLET;ORAL | 021078-002 | Jul 14, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline | MALARONE PEDIATRIC | atovaquone; proguanil hydrochloride | TABLET;ORAL | 021078-002 | Jul 14, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline | MALARONE PEDIATRIC | atovaquone; proguanil hydrochloride | TABLET;ORAL | 021078-002 | Jul 14, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline | MALARONE PEDIATRIC | atovaquone; proguanil hydrochloride | TABLET;ORAL | 021078-002 | Jul 14, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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