Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019860
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 2MG TABLET;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
11/22/1989 ORIG-1 Approval Type 3 - New Dosage Form 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
03/07/2019 SUPPL-33 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019860Orig1s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019860Orig1s033ltr.pdf
04/12/2017 SUPPL-32 Labeling-Container/Carton Labels Label (PDF)
Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019860Orig1s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019860Orig1s032ltr.pdf
02/21/2013 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

05/03/2012 SUPPL-29 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019860s029ltr.pdf
06/16/2004 SUPPL-20 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/2004/019860_S020_IMODIUM_CHEWABLE_TABLETS.pdf
09/26/2000 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

04/05/2001 SUPPL-18 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19860S18ltr.pdf
05/11/2000 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

11/29/1999 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

11/24/1999 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

09/04/1998 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/06/1997 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

01/03/1994 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/15/1994 SUPPL-10 Labeling

Label is not available on this site.

02/02/1995 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/02/1995 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

02/02/1995 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/22/1995 SUPPL-6 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/06/1993 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/23/1992 SUPPL-4 Labeling

Label is not available on this site.

01/06/1992 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/25/1991 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/07/2019 SUPPL-33 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019860Orig1s033lbl.pdf
04/12/2017 SUPPL-32 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019860Orig1s032lbl.pdf
04/12/2017 SUPPL-32 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019860Orig1s032ltr.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.

TABLET;ORAL; 2MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
IMODIUM A-D LOPERAMIDE HYDROCHLORIDE 2MG TABLET;ORAL Over-the-counter Yes 019860 J AND J CONSUMER INC
LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 2MG TABLET;ORAL Over-the-counter No 206548 AUROBINDO PHARMA LTD
LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 2MG TABLET;ORAL Over-the-counter No 075232 L PERRIGO CO
LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 2MG TABLET;ORAL Over-the-counter No 076497 LNK
LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 2MG TABLET;ORAL Over-the-counter No 074091 OHM LABS

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