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Details for New Drug Application (NDA): 088508

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NDA 088508 describes TUSSIGON, which is a drug marketed by King Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the TUSSIGON profile page.

The generic ingredient in TUSSIGON is homatropine methylbromide; hydrocodone bitartrate. There are four drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the homatropine methylbromide; hydrocodone bitartrate profile page.

Summary for NDA: 088508

Tradename:
TUSSIGON
Applicant:
King Pharms
Ingredient:
homatropine methylbromide; hydrocodone bitartrate
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 088508

Mechanism of ActionOpioid Agonists

Suppliers and Packaging for NDA: 088508

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TUSSIGON
homatropine methylbromide; hydrocodone bitartrate
TABLET;ORAL 088508 ANDA Pfizer Laboratories Div Pfizer Inc 61570-081 61570-081-01 100 TABLET in 1 BOTTLE (61570-081-01)
TUSSIGON
homatropine methylbromide; hydrocodone bitartrate
TABLET;ORAL 088508 ANDA Pfizer Laboratories Div Pfizer Inc 61570-102 61570-102-01 100 TABLET in 1 BOTTLE (61570-102-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1.5MG;5MG
Approval Date:Jul 30, 1985TE:AARLD:Yes


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