Details for New Drug Application (NDA): 206679
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The generic ingredient in FLOLIPID is simvastatin. There are forty drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the simvastatin profile page.
Summary for 206679
Tradename: | FLOLIPID |
Applicant: | Salerno Pharms |
Ingredient: | simvastatin |
Patents: | 2 |
Pharmacology for NDA: 206679
Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 206679
Suppliers and Packaging for NDA: 206679
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLOLIPID | simvastatin | SUSPENSION;ORAL | 206679 | NDA | Salerno Pharmaceuticals Co. | 29273-401 | 29273-401-04 | 150 mL in 1 BOTTLE, GLASS (29273-401-04) |
FLOLIPID | simvastatin | SUSPENSION;ORAL | 206679 | NDA | Salerno Pharmaceuticals Co. | 29273-402 | 29273-402-04 | 150 mL in 1 BOTTLE, GLASS (29273-402-04) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 20MG/5ML | ||||
Approval Date: | Apr 21, 2016 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Apr 26, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Feb 23, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 40MG/5ML | ||||
Approval Date: | Apr 21, 2016 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Apr 26, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? |
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