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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214864
Company: NOVITIUM PHARMA

Products on ANDA 214864

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BETAINE	BETAINE	1GM/SCOOPFUL	FOR SOLUTION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214864

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/23/2021	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214864Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 214864

BETAINE

FOR SOLUTION;ORAL; 1GM/SCOOPFUL
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BETAINE	BETAINE	1GM/SCOOPFUL	FOR SOLUTION;ORAL	Prescription	No	AB	210508	ETON
BETAINE	BETAINE	1GM/SCOOPFUL	FOR SOLUTION;ORAL	Prescription	No	AB	214864	NOVITIUM PHARMA
CYSTADANE	BETAINE	1GM/SCOOPFUL	FOR SOLUTION;ORAL	Prescription	Yes	AB	020576	RECORDATI RARE

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