Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219989
Company: SANDOZ INC

Products on ANDA 219989

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CARBIDOPA AND LEVODOPA	CARBIDOPA, LEVODOPA	35MG	CAPSULE, EXTENDED RELEASE	None (Tentative Approval)	None	No	No
CARBIDOPA AND LEVODOPA	CARBIDOPA, LEVODOPA	140MG	CAPSULE, EXTENDED RELEASE	None (Tentative Approval)	None	No	No
CARBIDOPA AND LEVODOPA	CARBIDOPA, LEVODOPA	87.5MG	CAPSULE, EXTENDED RELEASE	None (Tentative Approval)	None	No	No
CARBIDOPA AND LEVODOPA	CARBIDOPA, LEVODOPA	350MG	CAPSULE, EXTENDED RELEASE	None (Tentative Approval)	None	No	No
CARBIDOPA AND LEVODOPA	CARBIDOPA, LEVODOPA	70MG	CAPSULE, EXTENDED RELEASE	None (Tentative Approval)	None	No	No
CARBIDOPA AND LEVODOPA	CARBIDOPA, LEVODOPA	280MG	CAPSULE, EXTENDED RELEASE	None (Tentative Approval)	None	No	No
CARBIDOPA AND LEVODOPA	CARBIDOPA, LEVODOPA	52.5MG	CAPSULE, EXTENDED RELEASE	None (Tentative Approval)	None	No	No
CARBIDOPA AND LEVODOPA	CARBIDOPA, LEVODOPA	210MG	CAPSULE, EXTENDED RELEASE	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219989

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/12/2025	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.