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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040646
Company: IMPAX LABS INC

Products on ANDA 040646

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCORTISONE	HYDROCORTISONE	5MG	TABLET;ORAL	Prescription	AB	No	No
HYDROCORTISONE	HYDROCORTISONE	10MG	TABLET;ORAL	Prescription	AB	No	No
HYDROCORTISONE	HYDROCORTISONE	20MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040646

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/30/2007	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
07/21/2021	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
07/21/2021	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 040646

HYDROCORTISONE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CORTEF	HYDROCORTISONE	5MG	TABLET;ORAL	Prescription	Yes	AB	008697	PHARMACIA AND UPJOHN
HYDROCORTISONE	HYDROCORTISONE	5MG	TABLET;ORAL	Prescription	No	AB	214649	AUROBINDO PHARMA LTD
HYDROCORTISONE	HYDROCORTISONE	5MG	TABLET;ORAL	Prescription	No	AB	040646	IMPAX LABS INC
HYDROCORTISONE	HYDROCORTISONE	5MG	TABLET;ORAL	Prescription	No	AB	207029	STRIDES PHARMA

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CORTEF	HYDROCORTISONE	10MG	TABLET;ORAL	Prescription	Yes	AB	008697	PHARMACIA AND UPJOHN
HYDROCORTISONE	HYDROCORTISONE	10MG	TABLET;ORAL	Prescription	No	AB	214649	AUROBINDO PHARMA LTD
HYDROCORTISONE	HYDROCORTISONE	10MG	TABLET;ORAL	Prescription	No	AB	040646	IMPAX LABS INC
HYDROCORTISONE	HYDROCORTISONE	10MG	TABLET;ORAL	Prescription	No	AB	207029	STRIDES PHARMA

TABLET;ORAL; 20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CORTEF	HYDROCORTISONE	20MG	TABLET;ORAL	Prescription	Yes	AB	008697	PHARMACIA AND UPJOHN
HYDROCORTISONE	HYDROCORTISONE	20MG	TABLET;ORAL	Prescription	No	AB	214649	AUROBINDO PHARMA LTD
HYDROCORTISONE	HYDROCORTISONE	20MG	TABLET;ORAL	Prescription	No	AB	040646	IMPAX LABS INC
HYDROCORTISONE	HYDROCORTISONE	20MG	TABLET;ORAL	Prescription	No	AB	207029	STRIDES PHARMA

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