Drugs@FDA: FDA-Approved Drugs
Company: WEST-WARD PHARMS INT
| 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 | 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 |
|---|---|---|---|---|---|---|---|
| 07/15/1975 | 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 |
|---|---|---|---|---|---|
| 07/29/2020 | SUPPL-48 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/25/2016 | SUPPL-46 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/11/2000 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/07/1999 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/1998 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/07/1998 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/16/1998 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/05/1995 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/15/1995 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 01/27/1994 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 08/28/1992 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/31/1991 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 10/28/1991 | SUPPL-31 | Labeling |
Label is not available on this site. |
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| 06/12/1991 | SUPPL-29 | Labeling |
Label is not available on this site. |
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| 10/05/1989 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/1991 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/15/1989 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 02/17/1989 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 09/07/1988 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 10/22/1985 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/11/1988 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/11/1988 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/11/1988 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/07/1984 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/17/1983 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/17/1983 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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 |