Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019037
Company: JANSSEN PHARMS
Company: JANSSEN PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
IMODIUM | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION;ORAL | Discontinued | None | No | 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 |
---|---|---|---|---|---|---|---|
07/31/1984 | 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 |
---|---|---|---|---|---|
06/16/1987 | SUPPL-3 | Labeling |
Label is not available on this site. |
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06/02/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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10/29/1985 | SUPPL-1 | Labeling |
Label is not available on this site. |