Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 219585
Company: ASPIRO
Company: ASPIRO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZINC SULFATE | ZINC SULFATE | EQ 10MG BASE/10ML (EQ 1MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | No | No |
| ZINC SULFATE | ZINC SULFATE | EQ 25MG BASE/5ML (EQ 5MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | No | No |
| ZINC SULFATE | ZINC SULFATE | EQ 30MG BASE/10ML (EQ 3MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 05/01/2025 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
ZINC SULFATE
SOLUTION;INTRAVENOUS; EQ 10MG BASE/10ML (EQ 1MG BASE/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ZINC SULFATE | ZINC SULFATE | EQ 10MG BASE/10ML (EQ 1MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 209377 | AM REGENT |
| ZINC SULFATE | ZINC SULFATE | EQ 10MG BASE/10ML (EQ 1MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 218059 | APOTEX |
| ZINC SULFATE | ZINC SULFATE | EQ 10MG BASE/10ML (EQ 1MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 219585 | ASPIRO |
| ZINC SULFATE | ZINC SULFATE | EQ 10MG BASE/10ML (EQ 1MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216145 | FRESENIUS KABI USA |
| ZINC SULFATE | ZINC SULFATE | EQ 10MG BASE/10ML (EQ 1MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216249 | GLAND |
| ZINC SULFATE | ZINC SULFATE | EQ 10MG BASE/10ML (EQ 1MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214597 | NIVAGEN PHARMS INC |
| ZINC SULFATE | ZINC SULFATE | EQ 10MG BASE/10ML (EQ 1MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 217624 | RK PHARMA |
| ZINC SULFATE | ZINC SULFATE | EQ 10MG BASE/10ML (EQ 1MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 217074 | ZYDUS PHARMS |
SOLUTION;INTRAVENOUS; EQ 25MG BASE/5ML (EQ 5MG BASE/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ZINC SULFATE | ZINC SULFATE | EQ 25MG BASE/5ML (EQ 5MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 209377 | AM REGENT |
| ZINC SULFATE | ZINC SULFATE | EQ 25MG BASE/5ML (EQ 5MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 218059 | APOTEX |
| ZINC SULFATE | ZINC SULFATE | EQ 25MG BASE/5ML (EQ 5MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 219585 | ASPIRO |
| ZINC SULFATE | ZINC SULFATE | EQ 25MG BASE/5ML (EQ 5MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216145 | FRESENIUS KABI USA |
| ZINC SULFATE | ZINC SULFATE | EQ 25MG BASE/5ML (EQ 5MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216249 | GLAND |
| ZINC SULFATE | ZINC SULFATE | EQ 25MG BASE/5ML (EQ 5MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214597 | NIVAGEN PHARMS INC |
| ZINC SULFATE | ZINC SULFATE | EQ 25MG BASE/5ML (EQ 5MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 217624 | RK PHARMA |
| ZINC SULFATE | ZINC SULFATE | EQ 25MG BASE/5ML (EQ 5MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216135 | SOMERSET THERAPS LLC |
| ZINC SULFATE | ZINC SULFATE | EQ 25MG BASE/5ML (EQ 5MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 217074 | ZYDUS PHARMS |
SOLUTION;INTRAVENOUS; EQ 30MG BASE/10ML (EQ 3MG BASE/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ZINC SULFATE | ZINC SULFATE | EQ 30MG BASE/10ML (EQ 3MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 209377 | AM REGENT |
| ZINC SULFATE | ZINC SULFATE | EQ 30MG BASE/10ML (EQ 3MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 219585 | ASPIRO |
| ZINC SULFATE | ZINC SULFATE | EQ 30MG BASE/10ML (EQ 3MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216145 | FRESENIUS KABI USA |
| ZINC SULFATE | ZINC SULFATE | EQ 30MG BASE/10ML (EQ 3MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216249 | GLAND |
| ZINC SULFATE | ZINC SULFATE | EQ 30MG BASE/10ML (EQ 3MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214597 | NIVAGEN PHARMS INC |
| ZINC SULFATE | ZINC SULFATE | EQ 30MG BASE/10ML (EQ 3MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 217624 | RK PHARMA |
| ZINC SULFATE | ZINC SULFATE | EQ 30MG BASE/10ML (EQ 3MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216135 | SOMERSET THERAPS LLC |
| ZINC SULFATE | ZINC SULFATE | EQ 30MG BASE/10ML (EQ 3MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 217074 | ZYDUS PHARMS |