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Details for New Drug Application (NDA): 077273

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NDA 077273 describes TUSSICAPS, which is a drug marketed by Ecr Pharma and is included in one NDA. It is available from two suppliers. Additional details are available on the TUSSICAPS profile page.

The generic ingredient in TUSSICAPS is chlorpheniramine polistirex; hydrocodone polistirex. There are twenty-nine drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the chlorpheniramine polistirex; hydrocodone polistirex profile page.

Summary for NDA: 077273

Tradename:
TUSSICAPS
Applicant:
Ecr Pharma
Ingredient:
chlorpheniramine polistirex; hydrocodone polistirex
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 077273

Suppliers and Packaging for NDA: 077273

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TUSSICAPS
chlorpheniramine polistirex; hydrocodone polistirex
CAPSULE, EXTENDED RELEASE;ORAL 077273 ANDA VALEANT PHARMACEUTICALS NORTH AMERICA LLC 0187-0054 0187-0054-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0187-0054-01)
TUSSICAPS
chlorpheniramine polistirex; hydrocodone polistirex
CAPSULE, EXTENDED RELEASE;ORAL 077273 ANDA VALEANT PHARMACEUTICALS NORTH AMERICA LLC 0187-0054 0187-0054-20 20 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0187-0054-20)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 8MG MALEATE;EQ 10MG BITARTRATE
Approval Date:Sep 24, 2007TE:RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 4MG MALEATE;EQ 5MG BITARTRATE
Approval Date:Sep 24, 2007TE:RLD:No


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