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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019574
Company: CASPER PHARMA LLC

Products on NDA 019574

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
THALITONE	CHLORTHALIDONE	15MG	TABLET;ORAL	Prescription	None	Yes	No
THALITONE	CHLORTHALIDONE	25MG	TABLET;ORAL	Prescription	BX	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019574

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/20/1988	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/17/2019	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019574s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019574Orig1s017ltr.pdf
04/19/2018	SUPPL-16	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019574s016lbl.pdf
06/21/2001	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
06/01/2004	SUPPL-10	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19574slr010ltr.pdf
02/11/2000	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
03/16/1999	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
10/23/1997	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
10/26/1995	SUPPL-6	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
06/27/1994	SUPPL-5	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/08/1994	SUPPL-4	Labeling		Label is not available on this site.
06/26/1993	SUPPL-3	Labeling		Label is not available on this site.
10/15/1992	SUPPL-2	Labeling		Label is not available on this site.
02/12/1992	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 019574

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/17/2019	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019574s017lbl.pdf
04/19/2018	SUPPL-16	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019574s016lbl.pdf

Therapeutic Equivalents for NDA 019574

THALITONE

There are no Therapeutic Equivalents.

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