Assyro AI

Orange Book product · Brand (NDA)

HYCODAN

HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE

Brand (NDA)NDA 005213TE AARX GENUS
View HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE familyOpen on FDA Orange Book

At a glance

Jul 26, 1988

Approved

Brand (NDA)

Application

AA

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 26, 1988

    38 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE

Strength

1.5MG/5ML;5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

SYRUP

Route

ORAL

TE code

AA

Application

NDA 005213

Product number

002

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Agent CTA Background

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