Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085456
Company: CHARTWELL RX
Company: CHARTWELL RX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DEXAMETHASONE | DEXAMETHASONE | 1.5MG | TABLET;ORAL | Discontinued | None | 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 |
---|---|---|---|---|---|---|---|
02/08/1977 | 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 |
---|---|---|---|---|---|
04/17/1996 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
02/09/1994 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
12/31/1990 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
06/15/1990 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
08/12/1991 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/28/1991 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/31/1991 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/02/1990 | SUPPL-13 | Labeling |
Label is not available on this site. |