Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080399
Company: PRASCO
Company: PRASCO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DEXAMETHASONE | DEXAMETHASONE | 0.75MG | TABLET;ORAL | Discontinued | None | No | No |
DEXAMETHASONE | DEXAMETHASONE | 4MG | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
10/20/1971 | 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 |
---|---|---|---|---|---|
06/05/2024 | SUPPL-80 | Labeling-Package Insert |
Label is not available on this site. |
||
08/15/2022 | SUPPL-79 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
01/20/1984 | SUPPL-75 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/27/1983 | SUPPL-74 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/03/1982 | SUPPL-73 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/27/1982 | SUPPL-72 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/27/1982 | SUPPL-70 | Manufacturing (CMC) |
Label is not available on this site. |
DEXAMETHASONE
TABLET;ORAL; 4MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DEXAMETHASONE | DEXAMETHASONE | 4MG | TABLET;ORAL | Prescription | No | AB | 088481 | ALVOGEN |
DEXAMETHASONE | DEXAMETHASONE | 4MG | TABLET;ORAL | Prescription | No | AB | 215106 | AMNEAL |
DEXAMETHASONE | DEXAMETHASONE | 4MG | TABLET;ORAL | Prescription | No | AB | 217695 | APOTEX |
DEXAMETHASONE | DEXAMETHASONE | 4MG | TABLET;ORAL | Prescription | No | AB | 217001 | BIONPHARMA |
DEXAMETHASONE | DEXAMETHASONE | 4MG | TABLET;ORAL | Prescription | No | AB | 218372 | COREPHARMA |
DEXAMETHASONE | DEXAMETHASONE | 4MG | TABLET;ORAL | Prescription | Yes | AB | 084612 | HIKMA |
DEXAMETHASONE | DEXAMETHASONE | 4MG | TABLET;ORAL | Prescription | No | AB | 215604 | NOVITIUM PHARMA |
DEXAMETHASONE | DEXAMETHASONE | 4MG | TABLET;ORAL | Prescription | No | AB | 080399 | PRASCO |
DEXAMETHASONE | DEXAMETHASONE | 4MG | TABLET;ORAL | Prescription | No | AB | 216282 | ZYDUS LIFESCIENCES |