Details for New Drug Application (NDA): 213853
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NDA 213853 describes ATORVASTATIN CALCIUM, which is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Apotex, Apotex Inc, Aurobindo Pharma Ltd, Biocon Pharma, Cadila Pharms Ltd, Chartwell Rx, Dr Reddys, Dr Reddys Labs Ltd, Graviti Pharms, Hetero Labs Ltd V, Invagen Pharms, Lannett Co Inc, Laurus, Lepu Pharm, Lupin, Macleods Pharms, Mankind Pharma, Micro Labs Ltd India, MSN, Mylan Pharms Inc, Perrigo R And D, Sciegen Pharms, Shandong Xinhua, Strides Pharma, Sun Pharm Inds Ltd, Teva Pharms, Teva Pharms Inc, Teva Pharms Usa, Umedica, and Zydus Pharms, and is included in thirty-three NDAs. It is available from fifty-eight suppliers. Additional details are available on the ATORVASTATIN CALCIUM profile page.
The generic ingredient in ATORVASTATIN CALCIUM is atorvastatin calcium. There is one drug master file entry for this compound. Sixty 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 is one drug master file entry for this compound. Sixty suppliers are listed for this compound. Additional details are available on the atorvastatin calcium profile page.
Summary for 213853
| Tradename: | ATORVASTATIN CALCIUM |
| Applicant: | Umedica |
| Ingredient: | atorvastatin calcium |
| Patents: | 0 |
Pharmacology for NDA: 213853
| Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 213853
Suppliers and Packaging for NDA: 213853
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ATORVASTATIN CALCIUM | atorvastatin calcium | TABLET;ORAL | 213853 | ANDA | Umedica Laboratories USA Inc. | 60290-039 | 60290-039-01 | 90 TABLET in 1 BOTTLE (60290-039-01) |
| ATORVASTATIN CALCIUM | atorvastatin calcium | TABLET;ORAL | 213853 | ANDA | Umedica Laboratories USA Inc. | 60290-039 | 60290-039-02 | 1000 TABLET in 1 BOTTLE (60290-039-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Aug 19, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Aug 19, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 40MG BASE | ||||
| Approval Date: | Aug 19, 2020 | TE: | AB | RLD: | No | ||||
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