FDA Orange Book · active-ingredient family
Pyridoxine hydrochloride
Pyridoxine hydrochloride is approved in 11 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
0
Brand (NDA)
11
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Generic (ANDA) products (11)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PYRIDOXINE HYDROCHLORIDE | MYLAN INSTITUTIONAL | ANDA 204879 | — | Jul 14, 2016 | |
| PYRIDOXINE HYDROCHLORIDE | EPIC PHARMA LLC | ANDA 087967 | — | Oct 01, 1982 | |
| HEXA-BETALIN | LILLY | ANDA 080854 | — | Approved Prior to Jan 1, 1982 | |
| PYRIDOXINE HYDROCHLORIDE | BEL MAR | ANDA 080761 | — | Approved Prior to Jan 1, 1982 | |
| PYRIDOXINE HYDROCHLORIDE | DELL LABS | ANDA 083771 | — | Approved Prior to Jan 1, 1982 | |
| PYRIDOXINE HYDROCHLORIDE | DELL LABS | ANDA 083772 | — | Approved Prior to Jan 1, 1982 | |
| PYRIDOXINE HYDROCHLORIDE | DR REDDYS | ANDA 080572 | — | Approved Prior to Jan 1, 1982 | |
| PYRIDOXINE HYDROCHLORIDE | ELKINS SINN | ANDA 080581 | — | Approved Prior to Jan 1, 1982 | |
| PYRIDOXINE HYDROCHLORIDERLD | FRESENIUS KABI USA | ANDA 080618 | — | Approved Prior to Jan 1, 1982 | |
| PYRIDOXINE HYDROCHLORIDE | LUITPOLD | ANDA 080669 | — | Approved Prior to Jan 1, 1982 | |
| PYRIDOXINE HYDROCHLORIDE | WATSON LABS | ANDA 083760 | — | 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.
Pyridoxine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
