FDA Orange Book · active-ingredient family
Thiamine hydrochloride
Thiamine hydrochloride is approved in 21 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
0
Brand (NDA)
21
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Generic (ANDA) products (21)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| THIAMINE HYDROCHLORIDE | GLAND | ANDA 217800 | AP | Feb 24, 2025 | |
| THIAMINE HYDROCHLORIDE | ASPIRO | ANDA 218471 | AP | Nov 06, 2024 | |
| THIAMINE HYDROCHLORIDE | ONESOURCE SPECIALTY | ANDA 217181 | AP | Oct 29, 2024 | |
| THIAMINE HYDROCHLORIDE | CAPLIN | ANDA 215692 | AP | Mar 06, 2023 | |
| THIAMINE HYDROCHLORIDE | EUGIA PHARMA | ANDA 208703 | AP | Apr 20, 2022 | |
| THIAMINE HYDROCHLORIDE | SAGENT PHARMS INC | ANDA 206106 | AP | Dec 01, 2017 | |
| THIAMINE HYDROCHLORIDE | MYLAN INSTITUTIONAL | ANDA 091623 | AP | Jun 25, 2012 | |
| THIAMINE HYDROCHLORIDE | HOSPIRA | ANDA 040079 | — | May 03, 1996 | |
| THIAMINE HYDROCHLORIDE | EPIC PHARMA LLC | ANDA 087968 | — | Oct 01, 1982 | |
| BETALIN SRLD | LILLY | ANDA 080853 | — | Approved Prior to Jan 1, 1982 | |
| THIAMINE HYDROCHLORIDE | ABRAXIS PHARM | ANDA 080509 | — | Approved Prior to Jan 1, 1982 | |
| THIAMINE HYDROCHLORIDE | BEL MAR | ANDA 080718 | — | Approved Prior to Jan 1, 1982 | |
| THIAMINE HYDROCHLORIDE | BEL MAR | ANDA 080712 | — | Approved Prior to Jan 1, 1982 | |
| THIAMINE HYDROCHLORIDE | DELL LABS | ANDA 083775 | — | Approved Prior to Jan 1, 1982 | |
| THIAMINE HYDROCHLORIDE×2 | DR REDDYS | ANDA 080571 | AP | Approved Prior to Jan 1, 1982 | |
| THIAMINE HYDROCHLORIDERLD | FRESENIUS KABI USA | ANDA 080556 | AP | Approved Prior to Jan 1, 1982 | |
| THIAMINE HYDROCHLORIDE | LUITPOLD | ANDA 080667 | — | Approved Prior to Jan 1, 1982 | |
| THIAMINE HYDROCHLORIDE | PARKE DAVIS | ANDA 080770 | — | Approved Prior to Jan 1, 1982 | |
| THIAMINE HYDROCHLORIDE×2 | WATSON LABS | ANDA 083534 | — | Approved Prior to Jan 1, 1982 | |
| THIAMINE HYDROCHLORIDE | WEST-WARD PHARMS INT | ANDA 080575 | AP | Approved Prior to Jan 1, 1982 | |
| THIAMINE HYDROCHLORIDE | WYETH AYERST | ANDA 080553 | — | Approved Prior to Jan 1, 1982 |
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.
Thiamine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
