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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019487
Company: J AND J CONSUMER INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IMODIUM A-D LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION;ORAL Over-the-counter None Yes Yes
IMODIUM A-D LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION;ORAL Over-the-counter None Yes Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/01/1988 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
08/07/2019 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019487Orig1s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019487Orig1s034ltr.pdf
04/12/2017 SUPPL-32 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019487Orig1s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019487Orig1s032ltr.pdf
04/12/2017 SUPPL-30 Labeling-Container/Carton Labels

Label is not available on this site.
05/17/2016 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.
04/05/2016 SUPPL-28 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019487Orig1s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019487Orig1s028ltr.pdf
03/18/2015 SUPPL-27 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019487Orig1s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019487Orig1s027ltr.pdf
06/08/2005 SUPPL-23 Manufacturing (CMC)-Packaging Letter (PDF)
Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019487s023ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/019487_s023_IMODIUM A-D LIQUID.pdf
07/08/2004 SUPPL-22 Manufacturing (CMC)-Formulation Letter (PDF)
Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19487scf022ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019487_S022_IMODIUM_A-D LIQUID.pdf
06/16/2004 SUPPL-21 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19487slr021,19860slr020,20606slr009,21140slr003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019487_S021_IMODIUM A-D LIQUID.pdf
12/03/1999 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.
09/04/1998 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.
10/28/1996 SUPPL-15 Labeling

Label is not available on this site.
03/22/1996 SUPPL-14 Labeling

Label is not available on this site.
02/12/1996 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.
08/15/1994 SUPPL-12 Labeling

Label is not available on this site.
07/16/1992 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.
05/17/1991 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.
05/13/1993 SUPPL-8 Manufacturing (CMC)-Formulation

Label is not available on this site.
11/23/1992 SUPPL-7 Efficacy-New Indication

Label is not available on this site.
02/09/1990 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
01/29/1990 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.
01/05/1989 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.
12/06/1988 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
08/07/2019 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019487Orig1s034lbl.pdf
04/12/2017 SUPPL-32 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019487Orig1s032lbl.pdf
04/05/2016 SUPPL-28 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019487Orig1s028lbl.pdf
03/18/2015 SUPPL-27 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019487Orig1s027lbl.pdf

IMODIUM A-D

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

SUSPENSION;ORAL; 1MG/7.5ML
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
IMODIUM A-D LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION;ORAL Over-the-counter Yes 019487 J AND J CONSUMER INC
LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION;ORAL Over-the-counter No 091292 PERRIGO R AND D

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

SOLUTION;ORAL; 1MG/5ML
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
IMODIUM A-D LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION;ORAL Over-the-counter Yes 019487 J AND J CONSUMER INC
LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION;ORAL Over-the-counter No 074730 WOCKHARDT BIO AG
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