Details for New Drug Application (NDA): 090548
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NDA 090548 describes ATORVASTATIN CALCIUM, which is a drug marketed by Accord Hlthcare, Agnitio, Alkem Labs Ltd, Apotex Inc, Aurobindo Pharma Ltd, Biocon Pharma, Cadila Pharms Ltd, Dr Reddys, Dr Reddys Labs Ltd, Graviti Pharms, Hetero Labs Ltd V, Invagen Pharms, Lannett Co Inc, Laurus, Lepu Pharm, Lupin Ltd, Macleods Pharms Ltd, Mankind Pharma, Micro Labs Ltd India, MSN, Mylan Pharms Inc, Perrigo R And D, Sandoz Inc, Sciegen Pharms Inc, Shandong Xinhua, Strides Pharma, Sun Pharm Inds Ltd, Teva Pharms, Teva Pharms Usa, Umedica, and Zydus Pharms, and is included in thirty-two NDAs. It is available from sixty-three suppliers. Additional details are available on the ATORVASTATIN CALCIUM profile page.
The generic ingredient in ATORVASTATIN CALCIUM is atorvastatin calcium. There are sixty-two drug master file entries for this compound. Sixty-six 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-two drug master file entries for this compound. Sixty-six suppliers are listed for this compound. Additional details are available on the atorvastatin calcium profile page.
Summary for 090548
| Tradename: | ATORVASTATIN CALCIUM |
| Applicant: | Apotex Inc |
| Ingredient: | atorvastatin calcium |
| Patents: | 0 |
Pharmacology for NDA: 090548
| Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 090548
Suppliers and Packaging for NDA: 090548
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ATORVASTATIN CALCIUM | atorvastatin calcium | TABLET;ORAL | 090548 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8006 | 0615-8006-05 | 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8006-05) |
| ATORVASTATIN CALCIUM | atorvastatin calcium | TABLET;ORAL | 090548 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8006 | 0615-8006-07 | 7 TABLET, FILM COATED in 1 BLISTER PACK (0615-8006-07) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | May 29, 2012 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | May 29, 2012 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 40MG BASE | ||||
| Approval Date: | May 29, 2012 | TE: | AB | RLD: | No | ||||
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