Medicine
Sdamlo 10 mg/10 mg oral solution
Sdamlo 10 mg/10 mg oral solution is a prescription medicine containing Amlodipine for oral use, marketed by Pangea 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 Sdamlo at controlled room temperature, 20°C to 25°C (68°F to 77°F) with…
Key facts
- Active ingredient (INN)
- Amlodipine
- Brand
- Sdamlo
- Strength
- 10 mg/10 mg
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 10 bottles
- Marketing authorisation holder
- Pangea Pharmaceuticals
- Manufacturer
- Pangea Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store Sdamlo at controlled room temperature, 20°C to 25°C (68°F to 77°F) with excursions permitted to 15°C to 30°C (59°F to 86°F). Store and dispense in original packaging.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C08CA01 Amlodipine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 17 April 2026
- Identifiers
- RxCUI 2726058, 2726064, 2726065 +3DailyMed set ID 886a7f97-60a4-4206-a6c7-5206069ed487NDC 81279-135, 81279-133, 81279-134Application NDA219531
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 |
|---|---|---|---|
| 10 bottle in 1 carton / 2.5 mg in 1 bottle | 81279-133-10 | Pangea Pharmaceuticals | 2 October 2026 |
| 10 bottle in 1 carton / 5 mg in 1 bottle | 81279-134-10 | Pangea Pharmaceuticals | 17 April 2026 |
| 10 bottle in 1 carton / 10 mg in 1 bottle | 81279-135-10 | Pangea Pharmaceuticals | 2 October 2026 |
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 31 July 1992 | 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 Amlodipine
Clinical summary
Amlodipine is a dihydropyridine calcium channel blocker indicated for the treatment of hypertension, to lower blood pressure, among other approved uses. It is available as tablets, oral solution and oral suspension. MedsAcross supplies Amlodipine 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 AmlodipineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- amlodipine besylate prescribing information (Mylan Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Sdamlo 10 mg/10 mg oral 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.