Methamphetamine hydrochloride
Methamphetamine hydrochloride: 1 brand, 6 generics; first approved Feb 25, 2004; generic available.
Generic available: 6 ANDA applications approved.
Brand (NDA) products
- AJENAT PHARMSNDA 005378-4 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AA 10MG TABLET, EXTENDED RELEASE ORAL Discontinued - 5MG TABLET, EXTENDED RELEASE ORAL Discontinued - 15MG TABLET, EXTENDED RELEASE ORAL Discontinued -
Generic (ANDA) products (6)
- METHAMPHETAMINE HYDROCHLORIDEHIKMAANDA 2038462015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AA - METHAMPHETAMINE HYDROCHLORIDEDR REDDYS LABS SAANDA 0911892010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AA - METHAMPHETAMINE HYDROCHLORIDEABLEANDA 0405292004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued - - TEVAANDA 083889-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - METHAMPHETAMINE HYDROCHLORIDEREXARANDA 084931-2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued - 10MG TABLET ORAL Discontinued - - METHAMPHETAMINE HYDROCHLORIDETEVAANDA 086359-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued -
Listed patents
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
Approvals span 2004–2015 across 7 FDA applications.
Methamphetamine hydrochloride: 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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