Details for New Drug Application (NDA): 209288
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NDA 209288 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-four 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-seven 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-seven suppliers are listed for this compound. Additional details are available on the atorvastatin calcium profile page.
Summary for 209288
| Tradename: | ATORVASTATIN CALCIUM |
| Applicant: | Alkem Labs Ltd |
| Ingredient: | atorvastatin calcium |
| Patents: | 0 |
Pharmacology for NDA: 209288
| Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 209288
Suppliers and Packaging for NDA: 209288
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ATORVASTATIN CALCIUM | atorvastatin calcium | TABLET;ORAL | 209288 | ANDA | QPharma Inc | 42708-141 | 42708-141-30 | 30 TABLET, FILM COATED in 1 BOTTLE (42708-141-30) |
| ATORVASTATIN CALCIUM | atorvastatin calcium | TABLET;ORAL | 209288 | ANDA | QPharma Inc | 42708-144 | 42708-144-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42708-144-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Dec 21, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Dec 21, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 40MG BASE | ||||
| Approval Date: | Dec 21, 2018 | TE: | AB | RLD: | No | ||||
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