Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018337
Company: TARO PHARMS NORTH
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
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
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-Package Insert, Labeling-Container/Carton Labels 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
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; 650MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ACEPHEN ACETAMINOPHEN 650MG SUPPOSITORY;RECTAL Over-the-counter No 018060 G AND W LABS
ACEPHEN ACETAMINOPHEN 650MG SUPPOSITORY;RECTAL Over-the-counter No 072237 G AND W LABS
ACETAMINOPHEN ACETAMINOPHEN 650MG SUPPOSITORY;RECTAL Over-the-counter No 070608 PERRIGO NEW YORK
ACETAMINOPHEN ACETAMINOPHEN 650MG SUPPOSITORY;RECTAL Over-the-counter Yes 018337 TARO PHARMS NORTH

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
ACEPHEN ACETAMINOPHEN 325MG SUPPOSITORY;RECTAL Over-the-counter No 018060 G AND W LABS
ACEPHEN ACETAMINOPHEN 325MG SUPPOSITORY;RECTAL Over-the-counter No 072344 G AND W LABS
ACETAMINOPHEN ACETAMINOPHEN 325MG SUPPOSITORY;RECTAL Over-the-counter Yes 018337 TARO PHARMS NORTH

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
ACEPHEN ACETAMINOPHEN 120MG SUPPOSITORY;RECTAL Over-the-counter No 018060 G AND W LABS
ACETAMINOPHEN ACETAMINOPHEN 120MG SUPPOSITORY;RECTAL Over-the-counter No 070607 PERRIGO NEW YORK
ACETAMINOPHEN ACETAMINOPHEN 120MG SUPPOSITORY;RECTAL Over-the-counter Yes 018337 TARO PHARMS NORTH
NEOPAP ACETAMINOPHEN 120MG SUPPOSITORY;RECTAL Over-the-counter No 016401 POLYMEDICA

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 PHARMS NORTH

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