Details for New Drug Application (NDA): 202357
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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 202357
Tradename: | ATORVASTATIN CALCIUM |
Applicant: | Dr Reddys Labs Ltd |
Ingredient: | atorvastatin calcium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 202357
Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 202357
Suppliers and Packaging for NDA: 202357
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ATORVASTATIN CALCIUM | atorvastatin calcium | TABLET;ORAL | 202357 | ANDA | Dr. Reddy's Laboratories Limited | 55111-124 | 55111-124-05 | 500 TABLET in 1 BOTTLE (55111-124-05) |
ATORVASTATIN CALCIUM | atorvastatin calcium | TABLET;ORAL | 202357 | ANDA | Dr. Reddy's Laboratories Limited | 55111-124 | 55111-124-30 | 30 TABLET in 1 BOTTLE (55111-124-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 80MG BASE | ||||
Approval Date: | Jul 17, 2012 | TE: | AB | RLD: | No |
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