Medicine
Dotti 0.05 mg/day transdermal patch
Dotti 0.05 mg/day transdermal patch is a prescription medicine containing Estradiol for transdermal use, marketed by Amneal Pharmaceuticals, 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), excursions permitted between 15° to 30°C…
Key facts
- Active ingredient (INN)
- Estradiol
- Brand
- Dotti
- Strength
- 0.05 mg/day
- Dosage form
- Transdermal patch
- Route
- Transdermal
- Packs
- 8 pouches
- Marketing authorisation holder
- Amneal Pharmaceuticals
- Manufacturers
- Amneal PharmaceuticalsBryant Ranch Prepack
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F). Do not store unpouched.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- G03CA03 Estradiol
- HS code (indicative)
- 3004.39Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 4 February 2019
- Identifiers
- RxCUI 242891, 2110780, 241946 +7DailyMed set ID 75fc6d3a-49b6-47ad-b704-410692010d3a, 53016d30-6b5f-49da-ac16-85ef415a5805NDC 72162-2034, 65162-993Application ANDA211293
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 8 pouch in 1 carton / 1 d in 1 pouch | 65162-993-08 | Amneal Pharmaceuticals | 4 February 2019 |
| 8 pouch in 1 carton / 1 d in 1 pouch | 72162-2034-2 | Bryant Ranch Prepack | 4 February 2019 |
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 10 September 1986 | 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
Alternatives
Other makers and brands of Estradiol 0.05 mg/day transdermal patch.
- Estradiol 0.05 mg/day transdermal patchAvailable on request—US FDA12 packs
- Climara 0.05 mg/day transdermal patchAvailable on requestBayer HealthCare PharmaceuticalsUS FDA1 pack
- Lyllana 0.05 mg/day transdermal patchAvailable on requestAmneal PharmaceuticalsUS FDA1 pack
- Vivelle-Dot 0.05 mg/day transdermal patchAvailable on requestSandozUS FDA1 pack
Other strengths and forms of Estradiol
Clinical summary
Estradiol is an estrogen indicated for climara is an estrogen indicated for, among other approved uses. It is available as transdermal patches, tablets and gel for oral and topical use. MedsAcross supplies Estradiol 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 EstradiolFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Climara prescribing information (Bayer HealthCare Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Dotti 0.05 mg/day transdermal patch 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.