Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 008848
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PAMINE METHSCOPOLAMINE BROMIDE 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No
PAMINE FORTE METHSCOPOLAMINE BROMIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No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.

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.

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.

11/28/1980 SUPPL-14 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

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