Details for New Drug Application (NDA): 076477
✉ Email this page to a colleague
The generic ingredient in ATORVASTATIN CALCIUM 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 076477
Tradename: | ATORVASTATIN CALCIUM |
Applicant: | Sun Pharm Inds Ltd |
Ingredient: | atorvastatin calcium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 076477
Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 076477
Suppliers and Packaging for NDA: 076477
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ATORVASTATIN CALCIUM | atorvastatin calcium | TABLET;ORAL | 076477 | ANDA | ST. MARY'S MEDICAL PARK PHARMACY | 60760-829 | 60760-829-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-829-30) |
ATORVASTATIN CALCIUM | atorvastatin calcium | TABLET;ORAL | 076477 | ANDA | Sun Pharmaceutical Industries Inc. | 63304-827 | 63304-827-05 | 500 TABLET, FILM COATED in 1 BOTTLE (63304-827-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Nov 30, 2011 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
Approval Date: | Nov 30, 2011 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 40MG BASE | ||||
Approval Date: | Nov 30, 2011 | TE: | AB | RLD: | No |
Complete Access Available with Subscription