Application Nr Approved Date Route Status External Links
ANDA074246 1994-05-17 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Cimetidine Tablets Are Indicated In: Most Patients Heal Within 4 Weeks And There Is Rarely Reason To Use Cimetidine Tablets At Full Dosage For Longer Than 6 To 8 Weeks (see ). Concomitant Antacids Should Be Given As Needed For Relief Of Pain. However, Simultaneous Administration Of Cimetidine Tablets And Antacids Is Not Recommended, Since Antacids Have Been Reported To Interfere With The Absorption Of Cimetidine. (1) Short-Term Treatment Of Active Duodenal Ulcer. Dosage And Administration: Duodenal Ulcer Patients Have Been Maintained On Continued Treatment With Cimetidine Tablets 400 Mg At Bedtime For Periods Of Up To 5 Years. (2) Maintenance Therapy For Duodenal Ulcer Patients At Reduced Dosage After Healing Of Active Ulcer. There Is No Information Concerning Usefulness Of Treatment Periods Of Longer Than 8 Weeks. (3) Short-Term Treatment Of Active Benign Gastric Ulcer. Erosive Esophagitis Diagnosed By Endoscopy. Treatment Is Indicated For 12 Weeks For Healing Of Lesions And Control Of Symptoms. The Use Of Cimetidine Tablets Beyond 12 Weeks Has Not Been Established (see ). (4) Erosive Gastroesophageal Reflux (gerd). Dosage And Administration: Gerd (i.e., Zollinger-Ellison Syndrome, Systemic Mastocytosis, Multiple Endocrine Adenomas). (5) The Treatment Of Pathological Hypersecretory Conditions

All Formulated Excipients (12 Total)

Name Structure Kind Function Status
1. Hypromelloses HYPROMELLOSES Unresolved
2. Lecithin LECITHIN Unresolved
3. 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.
4. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
5. Polydextrose POLYDEXTROSE Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
6. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
7. Povidones POVIDONES Unresolved
8. Sodium Alginate SODIUM ALGINATE Unresolved BC-Boiler compound , STAB-Stabilizer REG-Food additives for which a petition has been filed and a regulation issued.
9. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
10. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
11. Triacetin TRIACETIN Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
12. Vanillin VANILLIN Molecular GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Cimetidine CIMETIDINE ZINC18115268

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