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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018337
Company: TARO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETAMINOPHEN ACETAMINOPHEN 650MG SUPPOSITORY;RECTAL Discontinued None Yes No
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
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-Package Insert, Labeling-Container/Carton Labels 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.

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) 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

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; 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
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