Details for New Drug Application (NDA): 213260
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NDA 213260 describes ATORVALIQ, which is a drug marketed by Cmp Dev Llc and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the ATORVALIQ profile page.
The generic ingredient in ATORVALIQ is atorvastatin calcium. There is one drug master file entry for this compound. Sixty suppliers are listed for this compound. Additional details are available on the atorvastatin calcium profile page.
The generic ingredient in ATORVALIQ is atorvastatin calcium. There is one drug master file entry for this compound. Sixty suppliers are listed for this compound. Additional details are available on the atorvastatin calcium profile page.
Summary for 213260
| Tradename: | ATORVALIQ |
| Applicant: | Cmp Dev Llc |
| Ingredient: | atorvastatin calcium |
| Patents: | 6 |
Pharmacology for NDA: 213260
| Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 213260
Suppliers and Packaging for NDA: 213260
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ATORVALIQ | atorvastatin calcium | SUSPENSION;ORAL | 213260 | NDA | CMP Pharma, Inc. | 46287-030 | 46287-030-01 | 150 mL in 1 BOTTLE (46287-030-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 20MG/5ML | ||||
| Approval Date: | Feb 1, 2023 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jun 7, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jun 7, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | AS AN ADJUNCT TO DIET TO REDUCE LOW-DENSITY LIPOPROTEIN CHOLESTEROL IN ADULTS AND PEDIATRIC PATIENTS AGED 10 YEARS AND OLDER WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jun 7, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | AS AN ADJUNCT TO OTHER LOW-DENSITY LIPOPROTEIN CHOLESTEROL (LDL-C) LOWERING THERAPIES, OR ALONE IF SUCH TREATMENTS ARE UNAVAILABLE, TO REDUCE LDL-C IN ADULTS AND PEDIATRIC PATIENTS AGED 10 YEARS AND OLDER WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA | ||||||||
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