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- Varenicline VARENICLINE TARTRATE 1 mg/1 Zydus Lifesciences Limited
Varenicline
- CHANTIX VARENICLINE TARTRATE 1 mg/1 Proficient Rx LP
- APO-VARENICLINE VARENICLINE TARTRATE 1 mg/1 Apotex Corp
- CHANTIX VARENICLINE TARTRATE 1 mg/1 Aphena Pharma Solutions - Tennessee, LLC
- VARENICLINE VARENICLINE TARTRATE 1 mg/1 Apotex Corp
- Varenicline VARENICLINE TARTRATE 1 mg/1 American Health Packaging
- Varenicline VARENICLINE TARTRATE 1 mg/1 Zydus Pharmaceuticals USA Inc.
- VARENICLINE VARENICLINE TARTRATE 1 mg/1 Golden State Medical Supply, Inc.
- Varenicline VARENICLINE TARTRATE 1 mg/1 Ascend Laboratories, LLC
- VARENICLINE VARENICLINE TARTRATE 1 mg/1 A-S Medication Solutions
- Varenicline VARENICLINE TARTRATE 1 mg/1 Camber Pharmaceuticals, Inc.
- Varenicline VARENICLINE TARTRATE 1 mg/1 Zydus Lifesciences Limited
- Varenicline VARENICLINE TARTRATE 1 mg/1 Major Pharmaceuticals
- Varenicline tartrate VARENICLINE TARTRATE 1 mg/1 Glenmark Pharmaceuticals Inc., USA
- CHANTIX VARENICLINE TARTRATE 1 mg/1 Pfizer Laboratories Div Pfizer Inc
- Varenicline VARENICLINE TARTRATE 1 mg/1 Par Pharmaceutical, Inc.
- Varenicline VARENICLINE TARTRATE 1 mg/1 AvKARE
- Varenicline VARENICLINE TARTRATE 1 mg/1 Ascend Laboratories, LLC
- Varenicline VARENICLINE TARTRATE 1 mg/1 Zydus Lifesciences Limited
Summary of product characteristics
Effective Time
20230519
Version
1
Spl Product Data Elements
Varenicline Varenicline VARENICLINE TARTRATE VARENICLINE ANHYDROUS DIBASIC CALCIUM PHOSPHATE CROSCARMELLOSE SODIUM HYPROMELLOSE 2910 (3 MPA.S) HYPROMELLOSE 2910 (6 MPA.S) MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE TITANIUM DIOXIDE TRIACETIN WHITE TO OFF-WHITE ZV1 Varenicline Varenicline VARENICLINE TARTRATE VARENICLINE ANHYDROUS DIBASIC CALCIUM PHOSPHATE CROSCARMELLOSE SODIUM HYPROMELLOSE 2910 (3 MPA.S) HYPROMELLOSE 2910 (6 MPA.S) MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE TITANIUM DIOXIDE TRIACETIN FD&C BLUE NO. 1 ALUMINUM LAKE Light Blue to Blue ZV2
Application Number
ANDA216723
Brand Name
Varenicline
Generic Name
Varenicline
Product Ndc
70771-1774
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Package Label Principal Display Panel
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1773-6 Varenicline Tablets, 0.5 mg 56 Tablets Rx only NDC 70771-1774-6 Varenicline Tablets, 1 mg 56 Tablets Rx only 0.5 mg label 1 mg label
Drug section
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