Details for New Drug Application (NDA): 091559
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NDA 091559 describes MALATHION, which is a drug marketed by Norvium Bioscience and Suven Pharms and is included in two NDAs. It is available from two suppliers. Additional details are available on the MALATHION profile page.
The generic ingredient in MALATHION is malathion. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the malathion profile page.
The generic ingredient in MALATHION is malathion. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the malathion profile page.
Summary for 091559
| Tradename: | MALATHION |
| Applicant: | Suven Pharms |
| Ingredient: | malathion |
| Patents: | 0 |
Pharmacology for NDA: 091559
| Mechanism of Action | Cholinesterase Inhibitors |
Medical Subject Heading (MeSH) Categories for 091559
Suppliers and Packaging for NDA: 091559
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MALATHION | malathion | LOTION;TOPICAL | 091559 | ANDA | Taro Pharmaceuticals U.S.A., Inc. | 51672-5293 | 51672-5293-4 | 1 BOTTLE in 1 CARTON (51672-5293-4) / 59 mL in 1 BOTTLE |
| MALATHION | malathion | LOTION;TOPICAL | 091559 | ANDA | Taro Pharmaceuticals U.S.A., Inc. | 51672-5294 | 51672-5294-4 | 1 BOTTLE in 1 CARTON (51672-5294-4) / 59 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | LOTION;TOPICAL | Strength | 0.5% | ||||
| Approval Date: | May 23, 2012 | TE: | RLD: | No | |||||
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