Medicine
Dorzolamide and Timolol 20 mg/5 mg per mL ophthalmic solution
Dorzolamide and Timolol 20 mg/5 mg per mL ophthalmic solution is a generic prescription medicine for ophthalmic use, made by 4 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20° to 25°C (68° to 77°F). Protect from light.
Key facts
- Active ingredient (INN)
- Dorzolamide and Timolol
- Brand
- Sold under the generic name
- Strength
- 20 mg/5 mg per mL
- Dosage form
- Ophthalmic solution
- Route
- Ophthalmic
- Packs
- 1 bottle, 5 mL, 10 mL and 3 more
- Manufacturers
- Leading PharmaSandozBryant Ranch PrepackSomerset Therapeutics
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 2 January 2010
- Identifiers
- RxCUI 1923432DailyMed set ID 78f39126-3e3b-4633-a4e0-c1f09a794eec, c9ae08c5-275d-44b3-9d1e-5d8fedc21b96, 17f04726-725f-4839-911d-47fc5e02baae +1NDC 61314-030, 69315-305, 70069-051 +1Application ANDA090604, ANDA205295, ANDA207523
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle, plastic in 1 carton / 5 mL in 1 bottle, plastic | 69315-305-05 | Leading Pharma | 18 May 2017 |
| 1 bottle, plastic in 1 carton / 10 mL in 1 bottle, plastic | 69315-305-10 | Leading Pharma | 18 May 2017 |
| 5 mL in 1 bottle | 61314-030-01 | Sandoz | 2 January 2010 |
| 10 mL in 1 bottle | 61314-030-02 | Sandoz | 2 January 2010 |
| 1 bottle in 1 carton / 10 mL in 1 bottle | 70069-051-01 | Somerset Therapeutics | 25 June 2019 |
| 10 mL in 1 bottle | 72162-2184-2 | Bryant Ranch Prepack | 7 December 2023 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 7 April 1998 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Dorzolamide and Timolol
Clinical summary
Dorzolamide and Timolol is a fixed-dose combination of a carbonic anhydrase inhibitor and a beta-adrenergic blocker indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. MedsAcross supplies Dorzolamide and Timolol for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Dorzolamide and TimololFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- COSOPT prescribing information (Thea Pharma) · U.S. National Library of Medicine, DailyMed
Need Dorzolamide and Timolol 20 mg/5 mg per mL ophthalmic solution for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.