DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 205519
The generic ingredient in ATORVASTATIN CALCIUM is atorvastatin calcium. There are sixty-one drug master file entries for this compound. Sixty-four suppliers are listed for this compound. Additional details are available on the atorvastatin calcium profile page.
Summary for 205519
Tradename: | ATORVASTATIN CALCIUM |
Applicant: | Sciegen Pharms Inc |
Ingredient: | atorvastatin calcium |
Patents: | 0 |
Therapeutic Class: | Cardiovascular Agents |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 205519
Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 205519
Suppliers and Packaging for NDA: 205519
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ATORVASTATIN CALCIUM | atorvastatin calcium | TABLET;ORAL | 205519 | ANDA | Marlex Pharmaceuticals Inc | 10135-649 | N | 10135-649-10 |
ATORVASTATIN CALCIUM | atorvastatin calcium | TABLET;ORAL | 205519 | ANDA | Marlex Pharmaceuticals Inc | 10135-650 | N | 10135-650-05 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | May 19, 2016 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
Approval Date: | May 19, 2016 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 40MG BASE | ||||
Approval Date: | May 19, 2016 | TE: | AB | RLD: | No |
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