Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215604
Company: NOVITIUM PHARMA
Company: NOVITIUM PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DEXAMETHASONE | DEXAMETHASONE | 1.5MG | TABLET;ORAL | Prescription | AB | No | No |
DEXAMETHASONE | DEXAMETHASONE | 4MG | TABLET;ORAL | Prescription | AB | No | No |
DEXAMETHASONE | DEXAMETHASONE | 6MG | TABLET;ORAL | Prescription | AB | No | No |
DEXAMETHASONE | DEXAMETHASONE | 0.5MG | TABLET;ORAL | Prescription | AB | No | No |
DEXAMETHASONE | DEXAMETHASONE | 0.75MG | 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 |
---|---|---|---|---|---|---|---|
08/08/2022 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/05/2023 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
DEXAMETHASONE
TABLET;ORAL; 1.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DEXAMETHASONE | DEXAMETHASONE | 1.5MG | TABLET;ORAL | Prescription | No | AB | 217695 | APOTEX |
DEXAMETHASONE | DEXAMETHASONE | 1.5MG | TABLET;ORAL | Prescription | Yes | AB | 084610 | HIKMA |
DEXAMETHASONE | DEXAMETHASONE | 1.5MG | TABLET;ORAL | Prescription | No | AB | 201270 | LARKEN LABS INC |
DEXAMETHASONE | DEXAMETHASONE | 1.5MG | TABLET;ORAL | Prescription | No | AB | 215604 | NOVITIUM PHARMA |
DEXAMETHASONE | DEXAMETHASONE | 1.5MG | TABLET;ORAL | Prescription | No | AB | 216282 | ZYDUS LIFESCIENCES |
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 | 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 |
TABLET;ORAL; 6MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DEXAMETHASONE | DEXAMETHASONE | 6MG | TABLET;ORAL | Prescription | No | AB | 088481 | ALVOGEN |
DEXAMETHASONE | DEXAMETHASONE | 6MG | TABLET;ORAL | Prescription | No | AB | 215106 | AMNEAL |
DEXAMETHASONE | DEXAMETHASONE | 6MG | TABLET;ORAL | Prescription | No | AB | 217695 | APOTEX |
DEXAMETHASONE | DEXAMETHASONE | 6MG | TABLET;ORAL | Prescription | No | AB | 217001 | BIONPHARMA |
DEXAMETHASONE | DEXAMETHASONE | 6MG | TABLET;ORAL | Prescription | Yes | AB | 088316 | HIKMA |
DEXAMETHASONE | DEXAMETHASONE | 6MG | TABLET;ORAL | Prescription | No | AB | 215604 | NOVITIUM PHARMA |
DEXAMETHASONE | DEXAMETHASONE | 6MG | TABLET;ORAL | Prescription | No | AB | 216282 | ZYDUS LIFESCIENCES |
TABLET;ORAL; 0.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DEXAMETHASONE | DEXAMETHASONE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 217695 | APOTEX |
DEXAMETHASONE | DEXAMETHASONE | 0.5MG | TABLET;ORAL | Prescription | Yes | AB | 084611 | HIKMA |
DEXAMETHASONE | DEXAMETHASONE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 215604 | NOVITIUM PHARMA |
DEXAMETHASONE | DEXAMETHASONE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 216282 | ZYDUS LIFESCIENCES |
TABLET;ORAL; 0.75MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DEXAMETHASONE | DEXAMETHASONE | 0.75MG | TABLET;ORAL | Prescription | No | AB | 217695 | APOTEX |
DEXAMETHASONE | DEXAMETHASONE | 0.75MG | TABLET;ORAL | Prescription | Yes | AB | 084613 | HIKMA |
DEXAMETHASONE | DEXAMETHASONE | 0.75MG | TABLET;ORAL | Prescription | No | AB | 215604 | NOVITIUM PHARMA |
DEXAMETHASONE | DEXAMETHASONE | 0.75MG | TABLET;ORAL | Prescription | No | AB | 216282 | ZYDUS LIFESCIENCES |