Application Nr Approved Date Route Status External Links
ANDA090618 2011-07-15 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage: Nizatidine Capsules Usp Are Indicated For Up To 8 Weeks For The Treatment Of Active Duodenal Ulcer. In Most Patients, The Ulcer Will Heal Within 4 Weeks. Nizatidine Capsules Usp Are Indicated For Maintenance Therapy For Duodenal Ulcer Patients At A Reduced Dosage Of 150 Mg H.s. After Healing Of An Active Duodenal Ulcer. The Consequences Of Continuous Therapy With Nizatidine For Longer Than 1 Year Are Not Known. Nizatidine Capsules Usp Are Indicated For Up To 12 Weeks For The Treatment Of Endoscopically Diagnosed Esophagitis, Including Erosive And Ulcerative Esophagitis, And Associated Heartburn Due To Gerd. Nizatidine Capsules Usp Are Indicated For Up To 8 Weeks For The Treatment Of Active Benign Gastric Ulcer. Before Initiating Therapy, Care Should Be Taken To Exclude The Possibility Of Malignant Gastric Ulceration.

All Formulated Excipients (11 Total)

Name Structure Kind Function Status
1. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
2. Povidones POVIDONES Unresolved
3. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
4. Fd&c Red No. 40 FD&C RED NO. 40 Molecular
5. Fd&c Yellow No. 6 FD&C YELLOW NO. 6 Molecular DYE-Dye
6. Alcohol ALCOHOL Molecular
7. Isopropyl Alcohol ISOPROPYL ALCOHOL Molecular
8. Butyl Alcohol BUTYL ALCOHOL Molecular MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
9. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
10. Ammonia AMMONIA Molecular
11. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Nizatidine NIZATIDINE ZINC1530736

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