Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 209377
Company: AM REGENT
Company: AM REGENT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZINC SULFATE | ZINC SULFATE | EQ 30MG BASE/10ML (EQ 3MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | Yes | Yes |
| ZINC SULFATE | ZINC SULFATE | EQ 25MG BASE/5ML (EQ 5MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | Yes | Yes |
| ZINC SULFATE | ZINC SULFATE | EQ 10MG BASE/10ML (EQ 1MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/18/2019 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209377s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209377Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/209377Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/28/2020 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209377s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209377Orig1s003ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/28/2020 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209377s003lbl.pdf | |
| 07/18/2019 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209377s000lbl.pdf |
ZINC SULFATE
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 | 216145 | FRESENIUS KABI USA |
| ZINC SULFATE | ZINC SULFATE | EQ 30MG BASE/10ML (EQ 3MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216249 | GLAND PHARMA LTD |
| 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 | 216135 | SOMERSET THERAPS LLC |
| ZINC SULFATE | ZINC SULFATE | EQ 30MG BASE/10ML (EQ 3MG 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 | 216145 | FRESENIUS KABI USA |
| ZINC SULFATE | ZINC SULFATE | EQ 25MG BASE/5ML (EQ 5MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216249 | GLAND PHARMA LTD |
| 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 | 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 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 | 216145 | FRESENIUS KABI USA |
| ZINC SULFATE | ZINC SULFATE | EQ 10MG BASE/10ML (EQ 1MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216249 | GLAND PHARMA LTD |
| 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 | 217074 | ZYDUS PHARMS |