DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 205519
NDA 205519 describes ATORVASTATIN CALCIUM, which is a drug marketed by Accord Hlthcare, Apotex Inc, Dr Reddys Labs Ltd, Invagen Pharms, Kremers Urban Pharms, Mylan Pharms Inc, Sandoz Inc, Sciegen Pharms Inc, Sun Pharm Inds Ltd, Teva Pharms, and Teva Pharms Usa, and is included in twelve NDAs. It is available from fifty-seven suppliers. Additional details are available on the ATORVASTATIN CALCIUM profile page.
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.
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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