Tolterodine Tartrate shortage — NL supply status & alternatives

Tolterodine Tartrate

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🇦🇺 AUST R 99393 · Mylan Health Pty Ltd

In supply · Australia

Detrol

In supply · 🇦🇺 Australia · short in🇨🇦 CA🇺🇸 US🇧🇪 BE🇳🇱 NL

In supply in Australia

Reading today’s signals…

✓ Can I substitute?

Per normal rules

Confirm with prescriber

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

No estimate

No estimate provided

Product attributes reference data we hold

Active ingredient (INN)

Brand names	Detrol

Therapeutic category	Auto-created by U.S. Food and Drug Administration — Drug Shortages scraper

Controlled substance	No

Marketing-authorisation holders	ACCORD HEALTHCARE LIMITED, ASPIRE PHARMA LIMITED, SYRI LIMITED, VIATRIS PRODUCTS LIMITED +2 more

Registrations on file	12

Patient information leaflet (PIL)	Not on file

Summary of product characteristics (SPC)	Not on file

Trade price 🇦🇺 Australia · awaiting price ingest

🇦🇺 AU

Ex-manufacturer

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Dispensed (DPMQ)

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Pack

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Not yet captured for Australia

Official pricing isn’t on file for this market yet. PBS (Australia), NHS Drug Tariff (United Kingdom) and CMS NADAC (United States) feeds are prioritised; this panel populates automatically once the data lands.

Other markets

🇺🇸 US

US$0.23

Acquisition

Substitution pathways 🇦🇺 Australia · TGA

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No substitution instrument in force

Dispense per normal rules, or refer to the prescriber. No active SSSI/S19A instrument detected for this medicine.

How long have past shortages lasted? from 1 resolved event

◷

~2 months

Historical pattern from resolved shortage records — not a prediction of this event.

Global API supply base 🇺🇸 FDA Drug Master Files · active Type II

15 API manufacturers

Manufacturers with an active Type II Drug Master File — i.e. cleared to supply this active ingredient into the US market. A proxy for how concentrated the global manufacturing base is.

Low concentration risk

Tapi Nl BVCipla LTDDr Reddys Laboratories LTDInterquim SAApitoria Pharma Private LTDHoliday Labs Mexico SA De Cv+9 more

Manufacturing countries: India, Mexico, Malta, Italy · Source: FDA List of Drug Master Files

FDA-approved products 🇺🇸 Drugs@FDA

Approved applications

Generic (ANDA)

Brand (NDA/BLA)

Feb 2021

Latest approval

Shortage status by regulator official notices

🇨🇦

Canada

HC · 2h ago

Medium

🇺🇸

United States

FDA · 3h ago

Medium

🇳🇱

Netherlands

CBG-MEB · 1mo ago

Medium

🇬🇷

EOF · 3mo ago

Resolved

🇧🇪

FAMHP · 3mo ago

Medium

Verified timeline regulator events

🇨🇦 28 Aug 2026

medium reported

🇨🇦 5 June 2026

medium reported

🇨🇦 3 June 2026

medium reported

🇨🇦 1 June 2026

medium reported

🇳🇱 13 May 2026

medium reported

🇨🇦 7 May 2026

medium reported

Sources official regulators

🇨🇦

verified 2h ago

verify ↗

🇺🇸

FDA

verified 3h ago

verify ↗

🇳🇱

CBG-MEB

verified 1mo ago

verify ↗

🇬🇷

EOF

verified 3mo ago

verify ↗

🇧🇪

FAMHP

verified 3mo ago

verify ↗

🇺🇸

FDA MedWatch

verified 4mo ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders12 registrations · 6 MA holders

Product	Strength	Form	Market	MA holder	Status
TOLTERODINE TARTRATE 1 MG FILM-COATED TABLET	1 MG	tablet	🇬🇧 GB	ACCORD HEALTHCARE LIMITED	Active
TOLTERODINE TARTRATE 2 MG FILM-COATED TABLET	2 MG	tablet	🇬🇧 GB	ACCORD HEALTHCARE LIMITED	Active
TOLTERODINE TARTRATE 1 MG FILM-COATED TABLETS	1 MG	tablet	🇬🇧 GB	ASPIRE PHARMA LIMITED	Active
TOLTERODINE TARTRATE 2 MG FILM-COATED TABLETS	2 MG	tablet	🇬🇧 GB	ASPIRE PHARMA LIMITED	Active
TOLTERODINE TARTRATE 2MG/5ML ORAL SUSPENSION	2MG	suspension	🇬🇧 GB	SYRI LIMITED	Active
TOLTERODINE TARTRATE 1MG FILM-COATED TABLETS	1MG	tablet	🇬🇧 GB	VIATRIS PRODUCTS LIMITED	Active
TOLTERODINE TARTRATE 2MG FILM-COATED TABLETS	2MG	tablet	🇬🇧 GB	VIATRIS PRODUCTS LIMITED	Active
Tolterodine Tartrate	1mg/1	tablet	🇺🇸 US	TEVA PHARMACEUTICALS USA, INC.	Active
Tolterodine Tartrate	2mg/1	tablet	🇺🇸 US	TEVA PHARMACEUTICALS USA, INC.	Active
Tolterodine Tartrate	4mg/1	capsule	🇺🇸 US	TEVA PHARMACEUTICALS USA, INC.	Active
DETRUSITOL tolterodine tartrate	1 mg	—	🇦🇺 AU	Mylan Health Pty Ltd	Active
DETRUSITOL tolterodine tartrate	2 mg	—	🇦🇺 AU	Mylan Health Pty Ltd	Active

Mederti Drug Report

Generated 1 July 2026 · Australia market · 6 regulatory sources

For health-professional reference only. Mederti aggregates shortage and substitution information from official regulatory sources. It is not clinical advice and data may be incomplete or delayed. Confirm any substitution or supply decision against the primary regulator source, the prescriber, and current clinical references (e.g. AMH) before acting. Terms.