Details for New Drug Application (NDA): 050742
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NDA 050742 describes STROMECTOL, which is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from one supplier. Additional details are available on the STROMECTOL profile page.
The generic ingredient in STROMECTOL is ivermectin. There are five drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ivermectin profile page.
The generic ingredient in STROMECTOL is ivermectin. There are five drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ivermectin profile page.
Summary for 050742
| Tradename: | STROMECTOL |
| Applicant: | Merck Sharp Dohme |
| Ingredient: | ivermectin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 050742
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| STROMECTOL | ivermectin | TABLET;ORAL | 050742 | NDA | Merck Sharp & Dohme LLC | 0006-0032 | 0006-0032-01 | 2 BLISTER PACK in 1 CARTON (0006-0032-01) / 10 TABLET in 1 BLISTER PACK |
| STROMECTOL | ivermectin | TABLET;ORAL | 050742 | NDA | Merck Sharp & Dohme LLC | 0006-0032 | 0006-0032-20 | 2 BLISTER PACK in 1 CARTON (0006-0032-20) / 10 TABLET in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Nov 22, 1996 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 3MG | ||||
| Approval Date: | Oct 8, 1998 | TE: | AB | RLD: | Yes | ||||
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