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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 214659


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NDA 214659 describes ATORVASTATIN CALCIUM, which is a drug marketed by Accord Hlthcare, ACI, Agnitio, Alkem Labs Ltd, Anbison Lab, Apotex Inc, 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, Mankind Pharma, Micro Labs Ltd India, MSN, Mylan Pharms Inc, Perrigo R And D, Sandoz Inc, Sciegen Pharms Inc, Sun Pharm Inds Ltd, Teva Pharms, Teva Pharms Usa, Umedica, and Zydus Pharms, and is included in thirty NDAs. It is available from fifty-nine 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-two suppliers are listed for this compound. Additional details are available on the atorvastatin calcium profile page.
Summary for 214659
Tradename:ATORVASTATIN CALCIUM
Applicant:Dr Reddys
Ingredient:atorvastatin calcium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 214659
Medical Subject Heading (MeSH) Categories for 214659
Suppliers and Packaging for NDA: 214659
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATORVASTATIN CALCIUM atorvastatin calcium TABLET;ORAL 214659 ANDA Dr. Reddy's Laboratories Inc 43598-830 43598-830-05 500 TABLET in 1 BOTTLE (43598-830-05)
ATORVASTATIN CALCIUM atorvastatin calcium TABLET;ORAL 214659 ANDA Dr. Reddy's Laboratories Inc 43598-830 43598-830-78 10 BLISTER PACK in 1 CARTON (43598-830-78) / 10 TABLET in 1 BLISTER PACK (43598-830-79)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Jul 14, 2021TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Jul 14, 2021TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 40MG BASE
Approval Date:Jul 14, 2021TE:ABRLD:No

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