Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019080
Company: ABBOTT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROSOM ESTAZOLAM 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
PROSOM ESTAZOLAM 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
12/26/1990 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
01/06/2003 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

06/04/2004 SUPPL-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19080slr007ltr.pdf
05/08/1998 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/13/1993 SUPPL-5 Labeling

Label is not available on this site.

03/10/1998 SUPPL-4 Manufacturing (CMC)-Formulation

Label is not available on this site.

11/24/1992 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/05/1991 SUPPL-2 Labeling

Label is not available on this site.

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