Details for New Drug Application (NDA): 206679
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NDA 206679 describes FLOLIPID, which is a drug marketed by Salerno Pharms and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the FLOLIPID profile page.
The generic ingredient in FLOLIPID is simvastatin. There are forty drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the simvastatin profile page.
The generic ingredient in FLOLIPID is simvastatin. There are forty drug master file entries for this compound. Thirty-eight 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: | 10,300,041 | Patent Expiration: | Apr 26, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 9,597,289 | 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: | 10,300,041 | Patent Expiration: | Apr 26, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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