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PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (nda011265)- (15MG/5ML;6.25MG/5ML)

DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE ANI PHARMS
15MG/5ML;6.25MG/5ML
No No
Expired Expired
None None
None No
Promethazine HCl Syrup Plain is 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 post-operative 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.
4 0 4
Total Other Developers None
Drugs with Suitability Yes
15MG/5ML;6.25MG/5ML ** ** - - 4
NDA Sales Available Total Generic Sales Available
No 4
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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Brand Name Generic Name Strength Dosage Route of Administration Innovator ParaIV

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