Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 008883
Company: APOTHECON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OPHTHAINE PROPARACAINE HYDROCHLORIDE 0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION/DROPS;OPHTHALMIC Discontinued None Yes No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
07/01/1953 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
08/08/1988 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

11/05/1986 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

05/03/1984 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/26/1985 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/22/1983 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

05/08/1982 SUPPL-9 Labeling

Label is not available on this site.

10/04/1979 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

08/24/1978 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

09/28/1978 SUPPL-6 Labeling

Label is not available on this site.

09/28/1978 SUPPL-5 Labeling

Label is not available on this site.

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