Drugs@FDA: FDA-Approved Drugs
Company: FOUGERA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PAMINE | METHSCOPOLAMINE BROMIDE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |
PAMINE FORTE | METHSCOPOLAMINE BROMIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |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 |
---|---|---|---|---|---|---|---|
04/09/1953 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
---|---|---|---|---|---|
05/16/2005 | SUPPL-25 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/008848s025ltr.pdf |
03/25/2003 | SUPPL-24 | Manufacturing (CMC)-Formulation |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08848scf024ltr.pdf |
06/22/2001 | SUPPL-23 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
11/08/1999 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
11/08/1999 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/24/1997 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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09/04/1986 | SUPPL-18 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/008848_S018_Pamine Tablets_APPROVAL PACKAGE.pdf |
08/02/1989 | SUPPL-17 | Labeling |
Label is not available on this site. |
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11/28/1980 | SUPPL-16 |
Label is not available on this site. |
|||
11/28/1980 | SUPPL-15 | Labeling |
Label is not available on this site. |
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11/28/1980 | SUPPL-14 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |