Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216249
Company: GLAND PHARMA LTD
Company: GLAND PHARMA LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
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 |
ZINC SULFATE | ZINC SULFATE | EQ 10MG BASE/10ML (EQ 1MG 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 |
---|---|---|---|---|---|---|---|
05/03/2022 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/216249Orig1s000ltr.pdf |
ZINC SULFATE
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 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 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 |