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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080399
Company: PRASCO

Products on ANDA 080399

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 080399

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
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.

Therapeutic Equivalents for ANDA 080399

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	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

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