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 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| DISCN | Dosage: | TABLET;ORAL | Strength | 6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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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