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 10MG PHOSPHATE/ML | INJECTABLE;INJECTION | Prescription | AP | No | 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 |
|---|---|---|---|---|---|---|---|
| 09/07/1982 | 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-41 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/29/2020 | SUPPL-39 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/03/2014 | SUPPL-36 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/07/2003 | SUPPL-29 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 09/05/2001 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/11/2000 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/07/1999 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/1998 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/07/1998 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/15/1995 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 04/19/1994 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/27/1994 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 10/28/1991 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 06/12/1991 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 01/14/1992 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/21/1989 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 05/26/1989 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 05/26/1989 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 02/07/1989 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 04/02/1987 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/21/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/21/1988 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/21/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/27/1984 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/31/1983 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/31/1983 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
DEXAMETHASONE SODIUM PHOSPHATE
INJECTABLE;INJECTION; EQ 10MG 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 10MG PHOSPHATE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 210966 | EUGIA PHARMA |
| DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE | EQ 10MG PHOSPHATE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 210967 | EUGIA PHARMA |
| DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE | EQ 10MG PHOSPHATE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 040572 | FRESENIUS KABI USA |
| DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE | EQ 10MG PHOSPHATE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 209192 | FRESENIUS KABI USA |
| DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE | EQ 10MG PHOSPHATE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 215654 | GLAND PHARMA LTD |
| DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE | EQ 10MG PHOSPHATE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 217797 | MICRO LABS |
| DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE | EQ 10MG PHOSPHATE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 040802 | MYLAN LABS LTD |
| DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE | EQ 10MG PHOSPHATE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211036 | SOMERSET THERAPS LLC |
| DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE | EQ 10MG PHOSPHATE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 087702 | WEST-WARD PHARMS INT |
| DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | DEXAMETHASONE SODIUM PHOSPHATE | EQ 10MG PHOSPHATE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 208690 | AMNEAL |
| DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | DEXAMETHASONE SODIUM PHOSPHATE | EQ 10MG PHOSPHATE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 040491 | FRESENIUS KABI USA |
| DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | DEXAMETHASONE SODIUM PHOSPHATE | EQ 10MG PHOSPHATE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 207442 | SOMERSET THERAPS LLC |