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- Amlodipine and atorvastatin AMLODIPINE BESYLATE 10 mg/1 Zydus Lifesciences Limited
Amlodipine and atorvastatin
- Amlodipine and atorvastatin AMLODIPINE BESYLATE 10 mg/1 Zydus Lifesciences Limited
- Amlodipine and Atorvastatin AMLODIPINE BESYLATE 10 mg/1 Bryant Ranch Prepack
- Amlodipine and atorvastatin AMLODIPINE BESYLATE 10 mg/1 Mylan Pharmaceuticals Inc.
- Caduet AMLODIPINE BESYLATE 10 mg/1 Pfizer Laboratories Div Pfizer Inc
- Amlodipine and Atorvastatin AMLODIPINE BESYLATE 10 mg/1 Apotex Corp.
- Caduet AMLODIPINE BESYLATE 10 mg/1 Pfizer Laboratories Div Pfizer Inc
- Amlodipine and atorvastatin AMLODIPINE BESYLATE 10 mg/1 Zydus Pharmaceuticals (USA) Inc.
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
70771-1466
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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