Orange Book product · Brand (NDA)
ZINC SULFATE
ZINC SULFATE
At a glance
Apr 15, 2020
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 15, 2020
6 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
ZINC SULFATE
Strength
EQ 10MG BASE/10ML (EQ 1MG BASE/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP
Application
NDA 209377
Product number
003
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 1987ZINC SULFATEBrand (NDA)
NDA 019229 · ABRAXIS PHARM
- 2025ZINC SULFATEGeneric (ANDA)
ANDA 217624 · STIRA
- 2025ZINC SULFATEGeneric (ANDA)
ANDA 219585 · ASPIRO
- 2024ZINC SULFATEGeneric (ANDA)
ANDA 218059 · APOTEX
- 2024ZINC SULFATEGeneric (ANDA)
ANDA 216135 · SOMERSET THERAPS LLC
- 2024ZINC SULFATEGeneric (ANDA)
ANDA 214597 · NIVAGEN PHARMS INC
- 2023ZINC SULFATEGeneric (ANDA)
ANDA 216249 · GLAND
- 2023ZINC SULFATEGeneric (ANDA)
ANDA 217074 · ZYDUS PHARMS
- 2022ZINC SULFATEGeneric (ANDA)
ANDA 216145 · FRESENIUS KABI USA
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.
