Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205304
Company: EDENBRIDGE PHARMS

Products on ANDA 205304

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CARBIDOPA	CARBIDOPA	25MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205304

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/17/2016	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
04/09/2025	SUPPL-5	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 205304

CARBIDOPA

TABLET;ORAL; 25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CARBIDOPA	CARBIDOPA	25MG	TABLET;ORAL	Prescription	No	AB	211055	AUROBINDO PHARMA
CARBIDOPA	CARBIDOPA	25MG	TABLET;ORAL	Prescription	No	AB	205304	EDENBRIDGE PHARMS
CARBIDOPA	CARBIDOPA	25MG	TABLET;ORAL	Prescription	No	AB	204763	NOVEL LABS INC
CARBIDOPA	CARBIDOPA	25MG	TABLET;ORAL	Prescription	No	AB	217961	REGCON HOLDINGS
CARBIDOPA	CARBIDOPA	25MG	TABLET;ORAL	Prescription	No	AB	209910	ZYDUS PHARMS
LODOSYN	CARBIDOPA	25MG	TABLET;ORAL	Prescription	Yes	AB	017830	ATON