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Medicines · US (FDA)

FDA 2017

Anticholinergics

Hydrocodone Bitartrate and Homatropine Methylbromide

Approved 6 Mar 2017OralSyrup

The FDA lists this product in 9 strengths and forms.

Official labelAsk Osler about it

On this page

Composition
Strengths and forms
Official product information

The table holds no label text for this product yet, only the facts beside it. The official product information has the full text.

Composition

Active ingredients: HOMATROPINE METHYLBROMIDE 1.5MG/5ML; HYDROCODONE BITARTRATE 5MG/5ML

Strengths and forms

The FDA lists each strength of a product separately; these pages share one label.

HOMATROPINE METHYLBROMIDE 1.5MG/5ML; HYDROCODONE BITARTRATE 5MG/5ML · SyrupANDA205731-001 · Discontinued
HOMATROPINE METHYLBROMIDE 1.5MG/5ML; HYDROCODONE BITARTRATE 5MG/5ML · SyrupANDA203535-001 · Prescription
HOMATROPINE METHYLBROMIDE 1.5MG/5ML; HYDROCODONE BITARTRATE 5MG/5ML · SyrupThis page
HOMATROPINE METHYLBROMIDE 1.5MG/5ML; HYDROCODONE BITARTRATE 5MG/5ML · SyrupANDA088017-001 · Prescription
HOMATROPINE METHYLBROMIDE 1.5MG/5ML; HYDROCODONE BITARTRATE 5MG/5ML · SyrupANDA210663-001 · Discontinued
HOMATROPINE METHYLBROMIDE 1.5MG/5ML; HYDROCODONE BITARTRATE 5MG/5ML · SyrupANDA207487-001 · Prescription
HOMATROPINE METHYLBROMIDE 1.5MG/5ML; HYDROCODONE BITARTRATE 5MG/5ML · Syrup

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

ANDA088008-001 · Prescription

HOMATROPINE METHYLBROMIDE 1.5MG/5ML; HYDROCODONE BITARTRATE 5MG/5ML · SyrupANDA040285-001 · Discontinued

HOMATROPINE METHYLBROMIDE 1.5MG/5ML; HYDROCODONE BITARTRATE 5MG/5ML · SyrupANDA040613-001 · Discontinued

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA204765.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Brand name: Hydrocodone Bitartrate and Homatropine Methylbromide
Active substance: homatropine methylbromide
Drug class: Anticholinergics, Belladonna alkaloids, semisynthetic, quaternary ammonium compounds
Route: Oral
Dosage form: Syrup
Applicant: Sciegen Pharms
Status: Discontinued
FDA approval: 6 Mar 2017
Application: ANDA204765-001
RxCUI: 27085