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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217695
Company: APOTEX

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXAMETHASONE DEXAMETHASONE 0.5MG TABLET;ORAL Prescription AB No No
DEXAMETHASONE DEXAMETHASONE 0.75MG TABLET;ORAL Prescription AB No No
DEXAMETHASONE DEXAMETHASONE 1MG TABLET;ORAL Prescription AB No No
DEXAMETHASONE DEXAMETHASONE 1.5MG TABLET;ORAL Prescription AB No No
DEXAMETHASONE DEXAMETHASONE 2MG TABLET;ORAL Prescription AB No No
DEXAMETHASONE DEXAMETHASONE 4MG TABLET;ORAL Prescription AB No No
DEXAMETHASONE DEXAMETHASONE 6MG 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
08/23/2023 ORIG-1 Approval STANDARD

Label is not available on this site.

DEXAMETHASONE

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

TABLET;ORAL; 1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXAMETHASONE DEXAMETHASONE 1MG TABLET;ORAL Prescription No AB 217695 APOTEX
DEXAMETHASONE DEXAMETHASONE 1MG TABLET;ORAL Prescription Yes AB 088306 HIKMA

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; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXAMETHASONE DEXAMETHASONE 2MG TABLET;ORAL Prescription No AB 216295 AMNEAL
DEXAMETHASONE DEXAMETHASONE 2MG TABLET;ORAL Prescription No AB 217695 APOTEX
DEXAMETHASONE DEXAMETHASONE 2MG TABLET;ORAL Prescription No AB 217538 BIONPHARMA
DEXAMETHASONE DEXAMETHASONE 2MG TABLET;ORAL Prescription Yes AB 087916 HIKMA
DEXAMETHASONE DEXAMETHASONE 2MG TABLET;ORAL Prescription No AB 217696 NOVITIUM PHARMA
DEXAMETHASONE DEXAMETHASONE 2MG TABLET;ORAL Prescription No AB 216283 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
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