FDA — authorised 27 July 1982
- Application: ANDA083677
- Marketing authorisation holder: MYLAN
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Deltasone in United States
FDA authorised Deltasone on 27 July 1982
Marketing authorisations
FDA — authorised 27 November 2002
- Application: ANDA088703
- Marketing authorisation holder: HIKMA
- Indication: Labeling
- Status: approved
FDA — authorised 5 June 2024
- Application: ANDA213386
- Marketing authorisation holder: AMNEAL
- Indication: Labeling
- Status: approved
The FDA approved Deltasone, manufactured by AMNEAL, for marketing in the United States on 2024-06-05. The approval was granted under application number ANDA213386, which followed a standard expedited pathway. The approved indication for Deltasone is listed in its labeling.
FDA — authorised 5 June 2024
- Application: ANDA208412
- Marketing authorisation holder: STRIDES PHARMA
- Indication: Labeling
- Status: approved
STRIDES PHARMA has been granted marketing authorisation by the FDA for Deltasone. The approval was issued on 2024-06-05 under application number ANDA208412. The indication approved is for the drug's labeling.
FDA — authorised 7 June 2024
- Application: ANDA084275
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Indication: Labeling
- Status: approved
The FDA approved Deltasone, manufactured by CHARTWELL MOLECULAR, on 2024-06-07. This approval was granted under the standard expedited pathway. The approved indication for Deltasone is listed in the labeling.
Deltasone in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Deltasone approved in United States?
Yes. FDA authorised it on 27 July 1982; FDA authorised it on 27 November 2002; FDA authorised it on 5 June 2024.
Who is the marketing authorisation holder for Deltasone in United States?
MYLAN holds the US marketing authorisation.