Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020606
Company: J AND J CONSUMER INC
Company: J AND J CONSUMER INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
IMODIUM MULTI-SYMPTOM RELIEF | LOPERAMIDE HYDROCHLORIDE; SIMETHICONE | 2MG;125MG | TABLET, CHEWABLE;ORAL | Discontinued | 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 |
---|---|---|---|---|---|---|---|
06/26/1997 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020606ap.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/12/2017 | SUPPL-17 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020606Orig1s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020606Orig1s017ltr.pdf | |
04/30/2008 | SUPPL-14 | Efficacy-Labeling Change With Clinical Data |
Letter (PDF)
Summary Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020606se8-014, 021140se8-011ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/020606se8-014, 021140se8-011_SUMR.pdf |
06/16/2004 | SUPPL-9 | 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/2004/020606_S009_IMODIUM_ADVANCED_CHEWABLE_TABLETS.pdf |
06/21/2001 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/29/1999 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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12/03/1999 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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10/04/1999 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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10/14/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/04/1998 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
09/10/1998 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/12/2017 | SUPPL-17 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020606Orig1s017lbl.pdf |