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Generated: March 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 011689

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NDA 011689 describes PHENERGAN, which is a drug marketed by Wyeth Ayerst, Mylan Pharms Inc, Delcor Asset Corp, and Ani Pharms, and is included in six NDAs. Additional details are available on the PHENERGAN profile page.

The generic ingredient in PHENERGAN is codeine phosphate; promethazine hydrochloride. There are nineteen drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the codeine phosphate; promethazine hydrochloride profile page.
Summary for 011689
Applicant:Mylan Pharms Inc
Ingredient:promethazine hydrochloride
Therapeutic Class:Antiemetics
Respiratory Tract Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 011689

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SUPPOSITORY;RECTALStrength50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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