Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084916
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE | EQ 4MG PHOSPHATE/ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 09/06/1977 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/28/2020 | SUPPL-69 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/03/2014 | SUPPL-66 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084916s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/040491Orig1s008,040572Orig1s002,084916Orig1s066ltr.pdf | |
| 07/28/2020 | SUPPL-65 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/05/2002 | SUPPL-57 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 06/13/2001 | SUPPL-56 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 07/20/1995 | SUPPL-54 | Labeling |
Label is not available on this site. |
||
| 01/11/1994 | SUPPL-53 | Labeling |
Label is not available on this site. |
||
| 06/13/1991 | SUPPL-52 | Labeling |
Label is not available on this site. |
||
| 09/13/1991 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/06/1991 | SUPPL-50 | Labeling |
Label is not available on this site. |
||
| 07/12/1989 | SUPPL-48 | Labeling |
Label is not available on this site. |
||
| 11/02/1988 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 06/13/1986 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/06/1984 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/03/1985 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/03/1985 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/17/1984 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/06/1983 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/19/1982 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/03/2014 | SUPPL-66 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084916s066lbl.pdf |
DEXAMETHASONE SODIUM PHOSPHATE
INJECTABLE;INJECTION; EQ 4MG PHOSPHATE/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE | EQ 4MG PHOSPHATE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 208689 | AMNEAL |
| DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE | EQ 4MG PHOSPHATE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 206781 | EUGIA PHARMA |
| DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE | EQ 4MG PHOSPHATE/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 084916 | FRESENIUS KABI USA |
| DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE | EQ 4MG PHOSPHATE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203129 | FRESENIUS KABI USA |
| DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE | EQ 4MG PHOSPHATE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 215654 | GLAND PHARMA LTD |
| DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE | EQ 4MG PHOSPHATE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211451 | HIKMA |
| DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE | EQ 4MG PHOSPHATE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 040803 | MYLAN LABS LTD |
| DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE | EQ 4MG PHOSPHATE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 207521 | SOMERSET |
| DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE | EQ 4MG PHOSPHATE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 084282 | WEST-WARD PHARMS INT |