Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019574
Company: CASPER PHARMA LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THALITONE CHLORTHALIDONE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
THALITONE CHLORTHALIDONE 25MG TABLET;ORAL Discontinued None No No
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.

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

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