Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019849
Company: FERA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DAPIPRAZOLE HYDROCHLORIDE DAPIPRAZOLE HYDROCHLORIDE 0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION/DROPS;OPHTHALMIC Discontinued None Yes No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
12/31/1990 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/17/2002 SUPPL-12 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019849_S012_REV-EYES.pdf
04/17/2002 SUPPL-11 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019849_S011_REV-EYES.pdf
03/16/1998 SUPPL-10 Labeling

Label is not available on this site.

04/01/1992 SUPPL-3 Labeling

Label is not available on this site.

06/28/1993 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

04/24/1991 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

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