FDA Orange Book · active-ingredient family
Zinc sulfate
Zinc sulfate is approved as 2 brand and 8 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ZINC SULFATE · NDA 209377
2
Brand (NDA)
8
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ZINC SULFATERLD×3 | AM REGENT | NDA 209377 | AP | Apr 15, 2020 | |
| ZINC SULFATE | ABRAXIS PHARM | NDA 019229 | — | May 05, 1987 |
Generic (ANDA) products (8)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ZINC SULFATE×3 | STIRA | ANDA 217624 | AP | Jun 10, 2025 | |
| ZINC SULFATE×3 | ASPIRO | ANDA 219585 | AP | May 01, 2025 | |
| ZINC SULFATE×2 | APOTEX | ANDA 218059 | AP | Oct 28, 2024 | |
| ZINC SULFATE×2 | SOMERSET THERAPS LLC | ANDA 216135 | AP | Jul 17, 2024 | |
| ZINC SULFATE×3 | NIVAGEN PHARMS INC | ANDA 214597 | AP | Jul 05, 2024 | |
| ZINC SULFATE×3 | GLAND | ANDA 216249 | AP | Sep 01, 2023 | |
| ZINC SULFATE×3 | ZYDUS PHARMS | ANDA 217074 | AP | Aug 22, 2023 | |
| ZINC SULFATE×3 | FRESENIUS KABI USA | ANDA 216145 | AP | Dec 27, 2022 |
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.
Zinc sulfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
