Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085368
Company: SEBELA IRELAND LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRAMOSONE HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 1%;1% CREAM;TOPICAL Prescription 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
01/07/1977 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/06/2001 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

09/21/2001 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

09/21/2001 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

02/05/2001 SUPPL-20 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

09/21/2000 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/11/2000 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

03/01/1999 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

08/20/1992 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

06/03/1992 SUPPL-15 Labeling

Label is not available on this site.

06/03/1992 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

06/03/1992 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

04/27/1992 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

06/03/1992 SUPPL-11 Labeling

Label is not available on this site.

11/07/1988 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

04/27/1992 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

04/27/1992 SUPPL-8 Labeling

Label is not available on this site.

12/21/1984 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/21/1984 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

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