Application Nr Approved Date Route Status External Links
ANDA040622 2006-07-18 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Promethazine Hydrochloride Tablets Are Useful For: Perennial And Seasonal Allergic Rhinitis. Vasomotor Rhinitis. Allergic Conjunctivitis Due To Inhalant Allergens And Foods. Mild, Uncomplicated Allergic Skin Manifestations Of Urticaria And Angioedema. Amelioration Of Allergic Reactions To Blood Or Plasma. Dermographism. Anaphylactic Reactions, As Adjunctive Therapy To Epinephrine And Other Standard Measures, After The Acute Manifestations Have Been Controlled. Preoperative, Postoperative, Or Obstetric Sedation. Prevention And Control Of Nausea And Vomiting Associated With Certain Types Of Anesthesia And Surgery. Therapy Adjunctive To Meperidine Or Other Analgesics For Control Of Postoperative Pain. Sedation In Both Children And Adults, As Well As Relief Of Apprehension And Production Of Light Sleep From Which The Patient Can Be Easily Aroused. Active And Prophylactic Treatment Of Motion Sickness. Antiemetic Therapy In Postoperative Patients.

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Edetate Disodium Anhydrous EDETATE DISODIUM ANHYDROUS Molecular
2. Hypromelloses HYPROMELLOSES Unresolved
3. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
4. 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.
5. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
6. Saccharin Sodium SACCHARIN SODIUM Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Promethazine Hydrochloride PROMETHAZINE HYDROCHLORIDE ZINC20250

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