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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209478
Company: CMP DEV LLC

Products on NDA 209478

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CAROSPIR	SPIRONOLACTONE	25MG/5ML	SUSPENSION;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209478

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/04/2017	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209478s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209478Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209478Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/24/2023	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209478s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209478Orig1s006ltr.pdf
06/25/2021	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209478s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209478Orig1s003ltr.pdf
07/15/2021	SUPPL-2	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209478Orig1s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209478Orig1s002ltr.pdf

Labels for NDA 209478

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/24/2023	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209478s006lbl.pdf
07/15/2021	SUPPL-2	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209478Orig1s002lbl.pdf
06/25/2021	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209478s003lbl.pdf
08/04/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209478s000lbl.pdf

Therapeutic Equivalents for NDA 209478

CAROSPIR

SUSPENSION;ORAL; 25MG/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CAROSPIR	SPIRONOLACTONE	25MG/5ML	SUSPENSION;ORAL	Prescription	Yes	AB	209478	CMP DEV LLC
SPIRONOLACTONE	SPIRONOLACTONE	25MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	215572	AMNEAL
SPIRONOLACTONE	SPIRONOLACTONE	25MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	218085	HETERO LABS LTD III

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