FDA — authorised 22 December 1971
- Application: ANDA080256
- Marketing authorisation holder: LILLY
- Local brand name: METHYLTESTOSTERONE
- Indication: TABLET — BUCCAL, SUBLINGUAL
- Status: approved
🇺🇸 Testred in United States
FDA authorised Testred on 22 December 1971
Marketing authorisations
FDA — authorised 24 July 1972
- Application: ANDA080839
- Marketing authorisation holder: INWOOD LABS
- Local brand name: METHYLTESTOSTERONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 September 1972
- Application: ANDA080973
- Marketing authorisation holder: INWOOD LABS
- Local brand name: METHYLTESTOSTERONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 December 1973
- Marketing authorisation holder: VALEANT PHARM INTL
- Status: approved
FDA — authorised 3 December 1973
- Application: ANDA083976
- Marketing authorisation holder: BAUSCH
- Local brand name: TESTRED
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 21 June 1974
- Application: ANDA084310
- Marketing authorisation holder: IMPAX LABS
- Local brand name: METHYLTESTOSTERONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 July 1974
- Application: ANDA084287
- Marketing authorisation holder: IMPAX LABS
- Local brand name: METHYLTESTOSTERONE
- Indication: TABLET — BUCCAL, SUBLINGUAL
- Status: approved
FDA — authorised 17 October 1974
- Application: ANDA080767
- Marketing authorisation holder: IMPAX LABS
- Local brand name: METHYLTESTOSTERONE
- Indication: TABLET — ORAL
- Status: approved
The FDA approved Testred, manufactured by Impax Labs, on 11 July 2025. The approval was granted through a standard expedited pathway. The approved indication for Testred is listed as 'Labeling', but the specific indication is not provided in the available data.
FDA — authorised 8 October 1976
- Application: ANDA084312
- Marketing authorisation holder: KV PHARM
- Local brand name: METHYLTESTOSTERONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 February 1977
- Application: ANDA085125
- Marketing authorisation holder: TABLICAPS
- Local brand name: METHYLTESTOSTERONE
- Indication: TABLET — BUCCAL, SUBLINGUAL
- Status: approved
FDA — authorised 3 August 1979
- Application: ANDA080281
- Marketing authorisation holder: SCHERING
- Local brand name: ORETON
- Indication: TABLET — BUCCAL
- Status: approved
FDA — authorised 9 February 1981
- Application: ANDA087147
- Marketing authorisation holder: BAUSCH
- Local brand name: ANDROID 25
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 February 1981
- Application: ANDA087222
- Marketing authorisation holder: VALEANT PHARM INTL
- Local brand name: ANDROID 5
- Indication: TABLET — BUCCAL
- Status: approved
FDA — authorised 9 February 1981
- Application: ANDA086450
- Marketing authorisation holder: VALEANT PHARMS NORTH
- Local brand name: ANDROID 10
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 November 1982
- Application: ANDA087092
- Marketing authorisation holder: LANNETT
- Local brand name: METHYLTESTOSTERONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 November 1982
- Application: ANDA087750
- Marketing authorisation holder: CHARTWELL
- Local brand name: VIRILON
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 27 January 1983
- Application: ANDA087111
- Marketing authorisation holder: LANNETT
- Local brand name: METHYLTESTOSTERONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 June 1993
- Application: ANDA080271
- Marketing authorisation holder: USL PHARMA
- Local brand name: METHYLTESTOSTERONE
- Indication: TABLET — BUCCAL, SUBLINGUAL
- Status: approved
FDA — authorised 21 September 2015
- Application: ANDA204851
- Marketing authorisation holder: IMPAX LABS INC
- Local brand name: METHYLTESTOSTERONE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 February 2022
- Application: ANDA215270
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: METHYLTESTOSTERONE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA084244
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: METHYLTESTOSTERONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA080313
- Marketing authorisation holder: TABLICAPS
- Local brand name: METHYLTESTOSTERONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA083836
- Marketing authorisation holder: PVT FORM
- Local brand name: METHYLTESTOSTERONE
- Indication: TABLET — BUCCAL, SUBLINGUAL
- Status: approved
FDA
- Application: ANDA084241
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: METHYLTESTOSTERONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA080310
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: METHYLTESTOSTERONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA080309
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: METHYLTESTOSTERONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA080308
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: METHYLTESTOSTERONE
- Indication: TABLET — BUCCAL, SUBLINGUAL
- Status: approved
FDA
- Application: ANDA084642
- Marketing authorisation holder: WEST WARD
- Local brand name: METHYLTESTOSTERONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA080214
- Marketing authorisation holder: PVT FORM
- Local brand name: METHYLTESTOSTERONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA084331
- Marketing authorisation holder: WEST WARD
- Local brand name: METHYLTESTOSTERONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085270
- Marketing authorisation holder: TABLICAPS
- Local brand name: METHYLTESTOSTERONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA080475
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: METHYLTESTOSTERONE
- Indication: TABLET — BUCCAL, SUBLINGUAL
- Status: approved
FDA
- Application: NDA003158
- Marketing authorisation holder: SCHERING
- Local brand name: ORETON METHYL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA003240
- Marketing authorisation holder: NOVARTIS
- Local brand name: METANDREN
- Indication: TABLET — BUCCAL, SUBLINGUAL
- Status: approved
Testred 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 Testred approved in United States?
Yes. FDA authorised it on 22 December 1971; FDA authorised it on 24 July 1972; FDA authorised it on 15 September 1972.
Who is the marketing authorisation holder for Testred in United States?
LILLY holds the US marketing authorisation.