Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 220119
Company: BIOCON PHARMA LIMITED

Products on ANDA 220119

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CARBIDOPA AND LEVODOPA	CARBIDOPA,LEVODOPA	36.25MG	CAPSULE, EXTENDED RELEASE	None (Tentative Approval)	None	No	No
CARBIDOPA AND LEVODOPA	CARBIDOPA,LEVODOPA	145MG	CAPSULE, EXTENDED RELEASE	None (Tentative Approval)	None	No	No
CARBIDOPA AND LEVODOPA	CARBIDOPA,LEVODOPA	23.75MG	CAPSULE, EXTENDED RELEASE	None (Tentative Approval)	None	No	No
CARBIDOPA AND LEVODOPA	CARBIDOPA,LEVODOPA	95MG	CAPSULE, EXTENDED RELEASE	None (Tentative Approval)	None	No	No
CARBIDOPA AND LEVODOPA	CARBIDOPA,LEVODOPA	245MG	CAPSULE, EXTENDED RELEASE	None (Tentative Approval)	None	No	No
CARBIDOPA AND LEVODOPA	CARBIDOPA,LEVODOPA	61.25MG	CAPSULE, EXTENDED RELEASE	None (Tentative Approval)	None	No	No
CARBIDOPA AND LEVODOPA	CARBIDOPA,LEVODOPA	48.75MG	CAPSULE, EXTENDED RELEASE	None (Tentative Approval)	None	No	No
CARBIDOPA AND LEVODOPA	CARBIDOPA,LEVODOPA	195MG	CAPSULE, EXTENDED RELEASE	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 220119

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/04/2025	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.