FDA Orange Book · active-ingredient family
Thiamine hydrochloride
Thiamine hydrochloride: 0 brands, 22 generics; first approved Oct 01, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 22 ANDA applications approved.
Brands (NDA)
0
Generics (ANDA)
22
Listed patents
0
Presentations
24
Generic (ANDA) products (22)
Abbreviated applications
- THIAMINE HYDROCHLORIDEMANKIND PHARMAANDA 2205132026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INJECTION Rx AP - THIAMINE HYDROCHLORIDEGLANDANDA 2178002025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INJECTION Rx AP - THIAMINE HYDROCHLORIDEASPIROANDA 2184712024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INJECTION Rx AP - THIAMINE HYDROCHLORIDEONESOURCE SPECIALTYANDA 2171812024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INJECTION Rx AP - THIAMINE HYDROCHLORIDECAPLINANDA 2156922023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INJECTION Rx AP - THIAMINE HYDROCHLORIDEEUGIA PHARMAANDA 2087032022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INJECTION Rx AP - THIAMINE HYDROCHLORIDESAGENT PHARMS INCANDA 2061062017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INJECTION Rx AP - THIAMINE HYDROCHLORIDEMYLAN INSTITUTIONALANDA 0916232012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INJECTION Rx AP - THIAMINE HYDROCHLORIDEHOSPIRAANDA 0400791996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INJECTION Discontinued — - THIAMINE HYDROCHLORIDEEPIC PHARMA LLCANDA 0879681982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INJECTION Discontinued — - BETALIN SRLDLILLYANDA 080853—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INJECTION Discontinued — - THIAMINE HYDROCHLORIDEABRAXIS PHARMANDA 080509—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INJECTION Discontinued — - THIAMINE HYDROCHLORIDEBEL MARANDA 080718—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INJECTION Discontinued — - THIAMINE HYDROCHLORIDEBEL MARANDA 080712—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/ML INJECTABLE INJECTION Discontinued — - THIAMINE HYDROCHLORIDEDELL LABSANDA 083775—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INJECTION Discontinued — - THIAMINE HYDROCHLORIDEDR REDDYSANDA 080571—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INJECTION Rx AP 200MG/ML INJECTABLE INJECTION Rx — - THIAMINE HYDROCHLORIDERLDRSFRESENIUS KABI USAANDA 080556—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INJECTION Rx AP - THIAMINE HYDROCHLORIDELUITPOLDANDA 080667—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INJECTION Discontinued — - THIAMINE HYDROCHLORIDEPARKE DAVISANDA 080770—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INJECTION Discontinued — - THIAMINE HYDROCHLORIDEWATSON LABSANDA 083534—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INJECTION Discontinued — 200MG/ML INJECTABLE INJECTION Discontinued — - THIAMINE HYDROCHLORIDEWEST-WARD PHARMS INTANDA 080575—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INJECTION Rx AP - THIAMINE HYDROCHLORIDEWYETH AYERSTANDA 080553—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INJECTION 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
2 mo ago
Approvals span 1982–2026 across 22 FDA applications.
Brand (NDA) 00%
Generic (ANDA) 22100%
Thiamine 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
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- 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.
