FDA Orange Book · active-ingredient family
Methyltestosterone
Methyltestosterone: 2 brands, 34 generics; first approved Nov 05, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 34 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
34
Listed patents
0
Presentations
46
Brand (NDA) products
Originator applications
- NOVARTISNDA 003240-4 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET BUCCAL, SUBLINGUAL Discontinued - 25MG TABLET BUCCAL, SUBLINGUAL Discontinued - 5MG TABLET BUCCAL, SUBLINGUAL Discontinued - 10MG TABLET BUCCAL, SUBLINGUAL Discontinued - - SCHERINGNDA 003158-2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - 25MG TABLET ORAL Discontinued -
Generic (ANDA) products (34)
Abbreviated applications
- METHYLTESTOSTERONENOVITIUM PHARMAANDA 2152702022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB - METHYLTESTOSTERONERSIMPAX LABS INCANDA 2048512015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB - METHYLTESTOSTERONELANNETTANDA 0871111983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued - - CHARTWELLANDA 0877501982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Discontinued - - METHYLTESTOSTERONELANNETTANDA 0870921982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - METHYLTESTOSTERONEHEATHERANDA 084967-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Discontinued - - TESTREDRLDBAUSCHANDA 083976-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Discontinued - - VALEANT PHARM INTLANDA 087222-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET BUCCAL Discontinued - - SCHERINGANDA 080281-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET BUCCAL Discontinued - - METHYLTESTOSTERONEIMPAX LABSANDA 084287-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET BUCCAL, SUBLINGUAL Discontinued - - METHYLTESTOSTERONELILLYANDA 080256-2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET BUCCAL, SUBLINGUAL Discontinued - 25MG TABLET BUCCAL, SUBLINGUAL Discontinued - - METHYLTESTOSTERONEPUREPAC PHARMANDA 080308-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET BUCCAL, SUBLINGUAL Discontinued - - METHYLTESTOSTERONEPUREPAC PHARMANDA 080475-3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET BUCCAL, SUBLINGUAL Discontinued - 10MG TABLET BUCCAL, SUBLINGUAL Discontinued - 25MG TABLET BUCCAL, SUBLINGUAL Discontinued - - METHYLTESTOSTERONEPVT FORMANDA 083836-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET BUCCAL, SUBLINGUAL Discontinued - - METHYLTESTOSTERONETABLICAPSANDA 085125-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET BUCCAL, SUBLINGUAL Discontinued - - METHYLTESTOSTERONEUSL PHARMAANDA 080271-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET BUCCAL, SUBLINGUAL Discontinued - - VALEANT PHARMS NORTHANDA 086450-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - BAUSCHANDA 087147-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued - - METHYLTESTOSTERONEIMPAX LABSANDA 080767-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx BP - METHYLTESTOSTERONEIMPAX LABSANDA 084310-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued - - METHYLTESTOSTERONEINWOOD LABSANDA 080839-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - METHYLTESTOSTERONEINWOOD LABSANDA 080973-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued - - METHYLTESTOSTERONEKV PHARMANDA 084312-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - METHYLTESTOSTERONEPARKE DAVISANDA 084244-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - METHYLTESTOSTERONEPARKE DAVISANDA 084241-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued - - METHYLTESTOSTERONEPUREPAC PHARMANDA 080309-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - METHYLTESTOSTERONEPUREPAC PHARMANDA 080310-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued - - METHYLTESTOSTERONEPVT FORMANDA 080214-3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued - 10MG TABLET ORAL Discontinued - 25MG TABLET ORAL Discontinued - - METHYLTESTOSTERONETABLICAPSANDA 080313-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - METHYLTESTOSTERONETABLICAPSANDA 085270-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued - - METHYLTESTOSTERONEWATSON LABSANDA 080933-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - METHYLTESTOSTERONEWATSON LABSANDA 080931-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued - - METHYLTESTOSTERONEWEST WARDANDA 084331-2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - 25MG TABLET ORAL Discontinued - - METHYLTESTOSTERONEWEST WARDANDA 084642-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued -
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
44 yr 7 mo ago
Most recent approval
4 yr 9 mo ago
Approvals span 1982–2022 across 36 FDA applications.
Brand (NDA) 26%
Generic (ANDA) 3494%
Methyltestosterone: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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