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FDA Drug information

Amlodipine and olmesartan medoxomil

Read time: 1 mins
Marketing start date: 29 Apr 2024

Summary of product characteristics


Effective Time

20221013

Version

4

Spl Product Data Elements

Amlodipine and olmesartan medoxomil Amlodipine and olmesartan medoxomil AMLODIPINE BESYLATE AMLODIPINE OLMESARTAN MEDOXOMIL OLMESARTAN ANHYDROUS LACTOSE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED SILICON DIOXIDE STARCH, CORN TALC TITANIUM DIOXIDE WHITE ROUND 927 Amlodipine and olmesartan medoxomil Amlodipine and olmesartan medoxomil AMLODIPINE BESYLATE AMLODIPINE OLMESARTAN MEDOXOMIL OLMESARTAN ANHYDROUS LACTOSE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM FERRIC OXIDE RED FERRIC OXIDE YELLOW HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED SILICON DIOXIDE STARCH, CORN TALC TITANIUM DIOXIDE ORANGE ROUND 928 Amlodipine and olmesartan medoxomil Amlodipine and olmesartan medoxomil AMLODIPINE BESYLATE AMLODIPINE OLMESARTAN MEDOXOMIL OLMESARTAN ANHYDROUS LACTOSE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED SILICON DIOXIDE STARCH, CORN TALC TITANIUM DIOXIDE PALE YELLOW ROUND 929 Amlodipine and olmesartan medoxomil Amlodipine and olmesartan medoxomil AMLODIPINE BESYLATE AMLODIPINE OLMESARTAN MEDOXOMIL OLMESARTAN ANHYDROUS LACTOSE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM FERRIC OXIDE RED FERRIC OXIDE YELLOW HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED SILICON DIOXIDE STARCH, CORN TALC TITANIUM DIOXIDE ORANGE ROUND 930

Application Number

ANDA207771

Brand Name

Amlodipine and olmesartan medoxomil

Generic Name

Amlodipine and olmesartan medoxomil

Product Ndc

70771-1188

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1186-3 Amlodipine and olmesartan medoxomil tablets, 5/20 mg Rx only 30 tablets NDC 70771-1187-3 Amlodipine and olmesartan medoxomil tablets, 10/20 mg Rx only 30 tablets NDC 70771-1188-3 Amlodipine and olmesartan medoxomil tablets, 5/40 mg Rx only 30 tablets NDC 70771-1189-3 Amlodipine and olmesartan medoxomil tablets, 10/40 mg Rx only 30 tablets Amlodipine and olmesartan medoxomil tablets Amlodipine and olmesartan medoxomil tablets Amlodipine and olmesartan medoxomil tablets Amlodipine and olmesartan medoxomil tablets

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