Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203412
Company: SLATE RUN PHARMA
Company: SLATE RUN PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AZITHROMYCIN | AZITHROMYCIN | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
10/09/2018 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203412Orig1s000TAltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/19/2020 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
AZITHROMYCIN
INJECTABLE;INJECTION; EQ 500MG BASE/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AZITHROMYCIN | AZITHROMYCIN | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 203294 | EUGIA PHARMA |
AZITHROMYCIN | AZITHROMYCIN | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065179 | FRESENIUS KABI USA |
AZITHROMYCIN | AZITHROMYCIN | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065501 | GLAND PHARMA LTD |
AZITHROMYCIN | AZITHROMYCIN | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065500 | HOSPIRA |
AZITHROMYCIN | AZITHROMYCIN | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065511 | HOSPIRA |
AZITHROMYCIN | AZITHROMYCIN | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 203412 | SLATE RUN PHARMA |
ZITHROMAX | AZITHROMYCIN | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 050733 | PFIZER |