Details for New Drug Application (NDA): 050742
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The generic ingredient in STROMECTOL is ivermectin. There are five drug master file entries for this compound. Twenty-one 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 | 0006-0032-20 | 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| DISCN | Dosage: | TABLET;ORAL | Strength | 6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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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