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 two patents protecting this drug. Additional details are available on the ATORVALIQ profile page.
The generic ingredient in ATORVALIQ is atorvastatin calcium. There are sixty-two drug master file entries for this compound. Sixty-three 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 are sixty-two drug master file entries for this compound. Sixty-three 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: | 2 |
| Formulation / Manufacturing: | see details |
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: | ⤷ Try a Trial | Patent Expiration: | Jun 7, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a 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: | ⤷ Try a 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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