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Details for New Drug Application (NDA): 022402

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NDA 022402 describes CODEINE SULFATE, which is a drug marketed by Roxane 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 NDA: 022402

Tradename:
CODEINE SULFATE
Applicant:
Roxane
Ingredient:
codeine sulfate
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 022402

Mechanism of ActionFull Opioid Agonists

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 0054-0244-24 4 BLISTER PACK in 1 BOX, UNIT-DOSE (0054-0244-24) > 25 TABLET in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Jul 16, 2009TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:Jul 16, 2009TE:ABRLD:No

Summary for product number 003

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


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