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FDA Drug information

Atorvastatin calcium

Read time: 1 mins
Marketing start date: 21 Jul 2024

Summary of product characteristics


Effective Time

20221031

Version

5

Spl Product Data Elements

atorvastatin calcium atorvastatin calcium ATORVASTATIN CALCIUM TRIHYDRATE ATORVASTATIN CALCIUM CARBONATE CROSCARMELLOSE SODIUM HYDROXYPROPYL CELLULOSE (110000 WAMW) HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 TITANIUM DIOXIDE TALC white to off-white OVAL 249 atorvastatin calcium atorvastatin calcium ATORVASTATIN CALCIUM TRIHYDRATE ATORVASTATIN CALCIUM CARBONATE CROSCARMELLOSE SODIUM HYDROXYPROPYL CELLULOSE (110000 WAMW) HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 TITANIUM DIOXIDE TALC white to off-white OVAL 250 atorvastatin calcium atorvastatin calcium ATORVASTATIN CALCIUM TRIHYDRATE ATORVASTATIN CALCIUM CARBONATE CROSCARMELLOSE SODIUM HYDROXYPROPYL CELLULOSE (110000 WAMW) HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE SODIUM PHOSPHATE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 TITANIUM DIOXIDE TALC white to off-white OVAL 251 atorvastatin calcium atorvastatin calcium ATORVASTATIN CALCIUM TRIHYDRATE ATORVASTATIN CALCIUM CARBONATE CROSCARMELLOSE SODIUM HYDROXYPROPYL CELLULOSE (110000 WAMW) HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 TITANIUM DIOXIDE TALC white to off-white OVAL 252

Application Number

ANDA206536

Brand Name

Atorvastatin calcium

Generic Name

atorvastatin calcium

Product Ndc

70771-1446

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

NDC 70771-1443-3 Atorvastatin Calcium Tablets, USP 10 mg Rx Only 30 Tablets NDC 70771-1444-3 Atorvastatin Calcium Tablets, USP 20 mg Rx Only 30 Tablets NDC 70771-1445-3 Atorvastatin Calcium Tablets, USP 40 mg Rx Only 30 Tablets NDC 70771-1446-3 Atorvastatin Calcium Tablets, USP 80 mg Rx Only 30 Tablets Atorvastatin Calcium Tablets, 10 mg Atorvastatin Calcium Tablets, 20 mg Atorvastatin Calcium Tablets, 40 mg Atorvastatin Calcium Tablets, 80 mg

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