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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211642
Company: NOVITIUM PHARMA

Products on ANDA 211642

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
THIOTHIXENE	THIOTHIXENE	1MG	CAPSULE;ORAL	Prescription	AB	No	No
THIOTHIXENE	THIOTHIXENE	2MG	CAPSULE;ORAL	Prescription	AB	No	No
THIOTHIXENE	THIOTHIXENE	5MG	CAPSULE;ORAL	Prescription	AB	No	Yes
THIOTHIXENE	THIOTHIXENE	10MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211642

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/05/2019	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211642Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 211642

THIOTHIXENE

CAPSULE;ORAL; 1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
THIOTHIXENE	THIOTHIXENE	1MG	CAPSULE;ORAL	Prescription	No	AB	215456	AMNEAL
THIOTHIXENE	THIOTHIXENE	1MG	CAPSULE;ORAL	Prescription	No	AB	211642	NOVITIUM PHARMA
THIOTHIXENE	THIOTHIXENE	1MG	CAPSULE;ORAL	Prescription	No	AB	071093	RISING

CAPSULE;ORAL; 2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
THIOTHIXENE	THIOTHIXENE	2MG	CAPSULE;ORAL	Prescription	No	AB	215456	AMNEAL
THIOTHIXENE	THIOTHIXENE	2MG	CAPSULE;ORAL	Prescription	No	AB	211642	NOVITIUM PHARMA
THIOTHIXENE	THIOTHIXENE	2MG	CAPSULE;ORAL	Prescription	No	AB	071093	RISING

CAPSULE;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
THIOTHIXENE	THIOTHIXENE	5MG	CAPSULE;ORAL	Prescription	No	AB	215456	AMNEAL
THIOTHIXENE	THIOTHIXENE	5MG	CAPSULE;ORAL	Prescription	No	AB	211642	NOVITIUM PHARMA
THIOTHIXENE	THIOTHIXENE	5MG	CAPSULE;ORAL	Prescription	No	AB	071093	RISING

CAPSULE;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
THIOTHIXENE	THIOTHIXENE	10MG	CAPSULE;ORAL	Prescription	No	AB	215456	AMNEAL
THIOTHIXENE	THIOTHIXENE	10MG	CAPSULE;ORAL	Prescription	No	AB	211642	NOVITIUM PHARMA
THIOTHIXENE	THIOTHIXENE	10MG	CAPSULE;ORAL	Prescription	No	AB	071093	RISING

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