FDA Orange Book · active-ingredient family
Lincomycin hydrochloride
Lincomycin hydrochloride is approved as 2 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:LINCOCIN · NDA 050317
2
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LINCOCINRLD | PFIZER | NDA 050317 | AP | Approved Prior to Jan 1, 1982 | |
| LINCOCIN×2 | PHARMACIA AND UPJOHN | NDA 050316 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LINCOMYCIN HYDROCHLORIDE | SLATE RUN PHARMA | ANDA 216662 | — | Dec 21, 2022 | |
| LINCOMYCIN HYDROCHLORIDE | GLAND | ANDA 215657 | AP | Sep 26, 2022 | |
| LINCOMYCIN HYDROCHLORIDE | MICRO LABS | ANDA 215082 | AP | Nov 08, 2021 | |
| LINCOMYCIN HYDROCHLORIDE | ARTHUR GRP | ANDA 212770 | AP | Mar 12, 2021 | |
| LINCOMYCIN HYDROCHLORIDE | XGEN PHARMS | ANDA 201746 | AP | Jun 04, 2015 | |
| LINCOMYCIN HYDROCHLORIDE | SLAYBACK | ANDA 063180 | — | Apr 16, 1991 |
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.
Lincomycin hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
