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FDA Drug information

Amlodipine and atorvastatin

Read time: 1 mins
Marketing start date: 19 Apr 2024
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Summary of product characteristics


Effective Time

20221013

Version

4

Spl Product Data Elements

Amlodipine and atorvastatin Amlodipine and atorvastatin AMLODIPINE BESYLATE AMLODIPINE ATORVASTATIN CALCIUM TRIHYDRATE ATORVASTATIN CALCIUM CARBONATE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM FD&C BLUE NO. 2 HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSES MAGNESIUM STEARATE POLYSORBATE 80 SILICON DIOXIDE STARCH, CORN TALC TITANIUM DIOXIDE BLUE BICONVEX F14 Amlodipine and atorvastatin Amlodipine and atorvastatin AMLODIPINE BESYLATE AMLODIPINE ATORVASTATIN CALCIUM TRIHYDRATE ATORVASTATIN CALCIUM CARBONATE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSES MAGNESIUM STEARATE POLYSORBATE 80 SILICON DIOXIDE STARCH, CORN TALC TITANIUM DIOXIDE WHITE TO OFF-WHITE ROUND 424 Amlodipine and atorvastatin Amlodipine and atorvastatin AMLODIPINE BESYLATE AMLODIPINE ATORVASTATIN CALCIUM TRIHYDRATE ATORVASTATIN CALCIUM CARBONATE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSES MAGNESIUM STEARATE POLYSORBATE 80 SILICON DIOXIDE STARCH, CORN TALC TITANIUM DIOXIDE WHITE TO OFF-WHITE ROUND 425 Amlodipine and atorvastatin Amlodipine and atorvastatin AMLODIPINE BESYLATE AMLODIPINE ATORVASTATIN CALCIUM TRIHYDRATE ATORVASTATIN CALCIUM CARBONATE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSES MAGNESIUM STEARATE POLYSORBATE 80 SILICON DIOXIDE STARCH, CORN TALC TITANIUM DIOXIDE WHITE TO OFF-WHITE ROUND 426 Amlodipine and atorvastatin Amlodipine and atorvastatin AMLODIPINE BESYLATE AMLODIPINE ATORVASTATIN CALCIUM TRIHYDRATE ATORVASTATIN CALCIUM CARBONATE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSES MAGNESIUM STEARATE POLYSORBATE 80 SILICON DIOXIDE STARCH, CORN TALC TITANIUM DIOXIDE WHITE TO OFF-WHITE OVAL 427 Amlodipine and atorvastatin Amlodipine and atorvastatin AMLODIPINE BESYLATE AMLODIPINE ATORVASTATIN CALCIUM TRIHYDRATE ATORVASTATIN CALCIUM CARBONATE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSES MAGNESIUM STEARATE POLYSORBATE 80 SILICON DIOXIDE STARCH, CORN TALC TITANIUM DIOXIDE WHITE TO OFF-WHITE OVAL 428 Amlodipine and atorvastatin Amlodipine and atorvastatin AMLODIPINE BESYLATE AMLODIPINE ATORVASTATIN CALCIUM TRIHYDRATE ATORVASTATIN CALCIUM CARBONATE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSES MAGNESIUM STEARATE POLYSORBATE 80 SILICON DIOXIDE STARCH, CORN TALC TITANIUM DIOXIDE WHITE TO OFF-WHITE OVAL 429 Amlodipine and atorvastatin Amlodipine and atorvastatin AMLODIPINE BESYLATE AMLODIPINE ATORVASTATIN CALCIUM TRIHYDRATE ATORVASTATIN CALCIUM CARBONATE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSES MAGNESIUM STEARATE POLYSORBATE 80 SILICON DIOXIDE STARCH, CORN TALC TITANIUM DIOXIDE WHITE TO OFF-WHITE OVAL 430 Amlodipine and atorvastatin Amlodipine and atorvastatin AMLODIPINE BESYLATE AMLODIPINE ATORVASTATIN CALCIUM TRIHYDRATE ATORVASTATIN CALCIUM CARBONATE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM FD&C BLUE NO. 2 HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSES MAGNESIUM STEARATE POLYSORBATE 80 SILICON DIOXIDE STARCH, CORN TALC TITANIUM DIOXIDE LIGHT BLUE TO BLUE o 431 Amlodipine and atorvastatin Amlodipine and atorvastatin AMLODIPINE BESYLATE AMLODIPINE ATORVASTATIN CALCIUM TRIHYDRATE ATORVASTATIN CALCIUM CARBONATE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM FD&C BLUE NO. 2 HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSES MAGNESIUM STEARATE POLYSORBATE 80 SILICON DIOXIDE STARCH, CORN TALC TITANIUM DIOXIDE LIGHT BLUE TO BLUE OVAL 432 Amlodipine and atorvastatin Amlodipine and atorvastatin AMLODIPINE BESYLATE AMLODIPINE ATORVASTATIN CALCIUM TRIHYDRATE ATORVASTATIN CALCIUM CARBONATE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM FD&C BLUE NO. 2 HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSES MAGNESIUM STEARATE POLYSORBATE 80 SILICON DIOXIDE STARCH, CORN TALC TITANIUM DIOXIDE LIGHT BLUE TO BLUE OVAL 433

Application Number

ANDA207762

Brand Name

Amlodipine and atorvastatin

Generic Name

Amlodipine and atorvastatin

Product Ndc

70771-1459

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1457-3 Amlodipine and atorvastatin tablets USP, 2.5 mg/ 10 mg 30 tablets Rx only NDC 70771-1458-3 Amlodipine and atorvastatin tablets USP, 2.5 mg/ 20 mg 30 tablets Rx only NDC 70771-1459-3 Amlodipine and atorvastatin tablets USP, 2.5 mg/ 40 mg 30 tablets Rx only NDC 70771-1460-3 Amlodipine and atorvastatin tablets USP, 5 mg/ 10 mg 30 tablets Rx only NDC 70771-1461-3 Amlodipine and atorvastatin tablets USP, 5 mg/ 20 mg 30 tablets Rx only NDC 70771-1462-3 Amlodipine and atorvastatin tablets USP, 5 mg/ 40 mg 30 tablets Rx only NDC 70771-1463-3 Amlodipine and atorvastatin tablets USP, 5 mg/ 80 mg 30 tablets Rx only NDC 70771-1464-3 Amlodipine and atorvastatin tablets USP, 10 mg/ 10 mg 30 tablets Rx only NDC 70771-1465-3 Amlodipine and atorvastatin tablets USP, 10 mg/ 20 mg 30 tablets Rx only NDC 70771-1466-3 Amlodipine and atorvastatin tablets USP, 10 mg/ 40 mg 30 tablets Rx only NDC 70771-1467-3 Amlodipine and atorvastatin tablets USP, 10 mg/80 mg 30 tablets Rx only Amlodipine and Atorvastatin Tablets, USP Amlodipine and Atorvastatin Tablets, USP Amlodipine and Atorvastatin Tablets, USP Amlodipine and Atorvastatin Tablets, USP Amlodipine and Atorvastatin Tablets, USP Amlodipine and Atorvastatin Tablets, USP Amlodipine and Atorvastatin Tablets, USP Amlodipine and Atorvastatin Tablets, USP Amlodipine and Atorvastatin Tablets, USP Amlodipine and Atorvastatin Tablets, USP Amlodipine and Atorvastatin Tablets, USP

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