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Details for Generic Name: promethazine hydrochloride

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Summary for Generic Name: promethazine hydrochloride

Drug Master File Entries: see list12
Therapeutic Class:Antiemetics
Respiratory Tract Agents

Clinical Trials for: promethazine hydrochloride

Pharmacogenetic Factors and Side Effects of Metoclopramide and Diphenhydramine
Status: Recruiting Condition: Drug Metabolism, Poor, CYP2D6-RELATED

Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine
Status: Completed Condition: Sleep

Therapeutic Effects of "Ibuprofen, Diphenhydramine and Aluminium MgS" on Recurrent Aphthous Stomatitis
Status: Completed Condition: Aphthous Stomatitis

Diphenhydramine for Acute Migraine
Status: Recruiting Condition: Migraine

Study of Promethazine for Treatment of Diabetic Gastroparesis
Status: Recruiting Condition: Diabetic Gastroparesis

Bioequivalence Study of Dr.Reddy's Ibuprofen and Diphenhydramine Citrate 200 mg/38 mg Caplets Under Fed Condition
Status: Completed Condition: Healthy

Bioequivalence Study of Dr.Reddy's Ibuprofen and Diphenhydramine Citrate 200 mg/38 mg Caplets Under Fasting Condition
Status: Completed Condition: Healthy

Morphine Versus Morphine-promethazine Combination for Acute Low Back Pain Relief in the Adult Emergency Department
Status: Not yet recruiting Condition: Low Back Pain

A Dose Ranging Effect of Preoperative Diphenhydramine on Postoperative Quality of Recovery After Ambulatory Surgery
Status: Completed Condition: Surgery; Pain

Study to Evaluate Diphenhydramine in Children and Adolescents
Status: Completed Condition: Allergic Rhinitis

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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma Farmaceutica
promethazine hydrochloride
INJECTABLE; INJECTION040737Apr 24, 2008RXNo<disabled><disabled>
promethazine hydrochloride
SYRUP; ORAL040718Apr 4, 2007RXNo<disabled><disabled>
promethazine hydrochloride
INJECTABLE; INJECTION083997Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
promethazine hydrochloride
INJECTABLE; INJECTION040785Sep 26, 2008RXNo<disabled><disabled>
Impax Labs
promethazine hydrochloride
TABLET; ORAL040791May 20, 2008RXNo<disabled><disabled>
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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