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Medicine

Silvadene 1% cream

Silver sulfadiazine · Topical · Pfizer Laboratories
Available on requestPrescription onlyUS FDA

Silvadene 1% cream is a prescription medicine containing Silver sulfadiazine for topical use, marketed by Pfizer Laboratories, 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

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Store at Controlled Room Temperature 20° to 25°C (68° to 77°F).

Key facts

Active ingredient (INN)
Silver sulfadiazine
Brand
Silvadene
Strength
1%
Dosage form
Cream
Route
Topical
Packs
1 tube, 400 g, 50 g and 5 more
Marketing authorisation holder
Pfizer Laboratories
Manufacturers
Pfizer LaboratoriesA-S Medication Solutions
Origin register
US FDA, United States
Storage
Store at Controlled Room Temperature 20° to 25°C (68° to 77°F).
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
D06BA01 Silver sulfadiazine
HS code (indicative)
3004.20Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
26 November 1973
Identifiers
RxCUI 106351, 208186DailyMed set ID 54b77a36-205b-4044-9ecb-c5130f0934b5, c437213a-1cd4-445e-a39f-bbcacb9f746fNDC 50090-0230, 61570-131Application NDA017381

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

PackCodeLabelerMarketed since
1 tube in 1 carton / 20 g in 1 tube61570-131-20Pfizer Laboratories26 November 1973
1 tube in 1 carton / 25 g in 1 tube61570-131-25Pfizer Laboratories26 May 2015
400 g in 1 jar61570-131-40Pfizer Laboratories26 November 1973
50 g in 1 jar61570-131-50Pfizer Laboratories26 November 1973
1 tube in 1 carton / 50 g in 1 tube61570-131-55Pfizer Laboratories26 May 2015
1 tube in 1 carton / 85 g in 1 tube61570-131-85Pfizer Laboratories26 November 1973
1000 g in 1 jar61570-131-98Pfizer Laboratories26 November 1973
1 tube in 1 carton / 20 g in 1 tube50090-0230-0A-S Medication Solutions29 June 2016

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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 26 November 1973Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS 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 Silver sulfadiazine 1% cream.

Compare all 4

Clinical summary

Silver sulfadiazine is a sulfonamide antibacterial indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second- and third-degree burns. It is available as cream for topical use. MedsAcross supplies Silver sulfadiazine 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 Silver sulfadiazine

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Silvadene 1% cream 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.