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Serving leading biopharmaceutical companies globally:

US Department of Justice
Farmers Insurance
Federal Trade Commission

Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022402

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NDA 022402 describes CODEINE SULFATE, which is a drug marketed by West-ward Pharms Int and Lannett Holdings Inc and is included in three NDAs. It is available from three 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. Three suppliers are listed for this compound. Additional details are available on the codeine sulfate profile page.
Summary for 022402
Applicant:West-ward Pharms Int
Ingredient:codeine sulfate
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 022402
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 022402
Suppliers and Packaging for NDA: 022402
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CODEINE SULFATE codeine sulfate TABLET;ORAL 022402 NDA West-Ward Pharmaceuticals Corp. 0054-0243 0054-0243-24 4 BLISTER PACK in 1 BOX, UNIT-DOSE (0054-0243-24) > 25 TABLET in 1 BLISTER PACK
CODEINE SULFATE codeine sulfate TABLET;ORAL 022402 NDA West-Ward Pharmaceuticals Corp. 0054-0244 0054-0244-25 100 TABLET in 1 BOTTLE (0054-0244-25)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Jul 16, 2009TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:Jul 16, 2009TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength60MG
Approval Date:Jul 16, 2009TE:ABRLD:Yes

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Queensland Health

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