Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 018337
Company: TARO

Products on NDA 018337

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACETAMINOPHEN	ACETAMINOPHEN	650MG	SUPPOSITORY;RECTAL	Over-the-counter	None	Yes	Yes
ACETAMINOPHEN	ACETAMINOPHEN	325MG	SUPPOSITORY;RECTAL	Over-the-counter	None	Yes	No
ACETAMINOPHEN	ACETAMINOPHEN	120MG	SUPPOSITORY;RECTAL	Over-the-counter	None	Yes	No
INFANTS' FEVERALL	ACETAMINOPHEN	80MG	SUPPOSITORY;RECTAL	Over-the-counter	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018337

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/22/1980	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	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
02/07/2020	SUPPL-35	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018337Orig1s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/018337Orig1s035ltr.pdf
08/12/2015	SUPPL-34	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018337Orig1s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018337Orig1s034ltr.pdf
01/05/2015	SUPPL-33	Manufacturing (CMC)		Label is not available on this site.
01/16/2014	SUPPL-32	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018337Orig1s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018337Orig1s032ltr.pdf
10/20/2010	SUPPL-29	Labeling		Label is not available on this site.
04/05/2010	SUPPL-28	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018337s028ltr.pdf
06/27/2008	SUPPL-25	Labeling-Container/Carton Labels, Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018337s025ltr.pdf
11/02/2007	SUPPL-24	Labeling-Container/Carton Labels, Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018337s024ltr.pdf
10/09/2002	SUPPL-20	Manufacturing (CMC)-Control		Label is not available on this site.
09/21/2000	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
06/15/1994	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
08/26/1992	SUPPL-13	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018337Orig1s013.pdf
01/28/1993	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
06/08/1988	SUPPL-8	Labeling		Label is not available on this site.

Labels for NDA 018337

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Url
02/07/2020	SUPPL-35	Labeling-Container/Carton Labels	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018337Orig1s035lbl.pdf
08/12/2015	SUPPL-34	Labeling-Container/Carton Labels	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018337Orig1s034lbl.pdf
01/16/2014	SUPPL-32	Labeling-Container/Carton Labels	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018337Orig1s032lbl.pdf

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

ACETAMINOPHEN

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SUPPOSITORY;RECTAL; 650MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
ACETAMINOPHEN	ACETAMINOPHEN	650MG	SUPPOSITORY;RECTAL	Over-the-counter	No	070608	PERRIGO NEW YORK
ACETAMINOPHEN	ACETAMINOPHEN	650MG	SUPPOSITORY;RECTAL	Over-the-counter	Yes	018337	TARO

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SUPPOSITORY;RECTAL; 325MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
ACETAMINOPHEN	ACETAMINOPHEN	325MG	SUPPOSITORY;RECTAL	Over-the-counter	Yes	018337	TARO

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SUPPOSITORY;RECTAL; 120MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
ACETAMINOPHEN	ACETAMINOPHEN	120MG	SUPPOSITORY;RECTAL	Over-the-counter	No	070607	PERRIGO NEW YORK
ACETAMINOPHEN	ACETAMINOPHEN	120MG	SUPPOSITORY;RECTAL	Over-the-counter	Yes	018337	TARO

INFANTS' FEVERALL

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SUPPOSITORY;RECTAL; 80MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
INFANTS' FEVERALL	ACETAMINOPHEN	80MG	SUPPOSITORY;RECTAL	Over-the-counter	Yes	018337	TARO