Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020448
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 A-D EZ CHEWS | LOPERAMIDE HYDROCHLORIDE | 2MG | 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 |
---|---|---|---|---|---|---|---|
07/24/1997 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020448_imodium-ad_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/12/2017 | SUPPL-11 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020448Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020448Orig1s011ltr.pdf | |
05/22/2014 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/20/2014 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/27/2013 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/11/2007 | SUPPL-4 | Manufacturing (CMC)-Formulation |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020448s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020448s004ltr.pdf | |
09/10/1998 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/04/1998 | 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 |
---|---|---|---|---|---|
04/12/2017 | SUPPL-11 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020448Orig1s011lbl.pdf | |
01/11/2007 | SUPPL-4 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020448s004lbl.pdf |