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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202489
Company: THINQ PHARM-CRO PVT

Products on ANDA 202489

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TINIDAZOLE	TINIDAZOLE	250MG	TABLET;ORAL	Prescription	AB	No	No
TINIDAZOLE	TINIDAZOLE	500MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202489

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/09/2013	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/12/2023	SUPPL-6	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
05/26/2020	SUPPL-3	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
10/09/2013	SUPPL-1		Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202489Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202489Orig1s000ltr.pdf

Labels for ANDA 202489

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/09/2013	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202489Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 202489

TINIDAZOLE

TABLET;ORAL; 250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TINDAMAX	TINIDAZOLE	250MG	TABLET;ORAL	Prescription	Yes	AB	021618	MISSION PHARMA
TINIDAZOLE	TINIDAZOLE	250MG	TABLET;ORAL	Prescription	No	AB	202044	CHARTWELL RX
TINIDAZOLE	TINIDAZOLE	250MG	TABLET;ORAL	Prescription	No	AB	203808	EDENBRIDGE PHARMS
TINIDAZOLE	TINIDAZOLE	250MG	TABLET;ORAL	Prescription	No	AB	202489	THINQ PHARM-CRO PVT

TABLET;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TINDAMAX	TINIDAZOLE	500MG	TABLET;ORAL	Prescription	Yes	AB	021618	MISSION PHARMA
TINIDAZOLE	TINIDAZOLE	500MG	TABLET;ORAL	Prescription	No	AB	202044	CHARTWELL RX
TINIDAZOLE	TINIDAZOLE	500MG	TABLET;ORAL	Prescription	No	AB	203808	EDENBRIDGE PHARMS
TINIDAZOLE	TINIDAZOLE	500MG	TABLET;ORAL	Prescription	No	AB	202489	THINQ PHARM-CRO PVT

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