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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 202245

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NDA 202245 describes CODEINE SULFATE, which is a drug marketed by Hikma and Lannett Co Inc and is included in three NDAs. It is available from two suppliers. Additional details are available on the CODEINE SULFATE profile page.

The generic ingredient in CODEINE SULFATE is codeine sulfate. There are nineteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the codeine sulfate profile page.

Summary for 202245

Tradename:	CODEINE SULFATE
Applicant:	Hikma
Ingredient:	codeine sulfate
Patents:	0

Medical Subject Heading (MeSH) Categories for 202245

Analgesics, Opioid
Antitussive Agents
Narcotics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	30MG/5ML
Approval Date:	Jun 30, 2011	TE:		RLD:	No

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