Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086576
Company: FOUGERA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TYZINE TETRAHYDROZOLINE HYDROCHLORIDE 0.1% SOLUTION;NASAL Prescription None No No
TYZINE TETRAHYDROZOLINE HYDROCHLORIDE 0.05% SOLUTION;NASAL Prescription None No Yes
TYZINE TETRAHYDROZOLINE HYDROCHLORIDE 0.1% SPRAY;NASAL Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/30/1979 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
11/13/2000 SUPPL-17 Labeling

Label is not available on this site.

11/13/2000 SUPPL-16 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/13/2000 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/13/2000 SUPPL-14 Manufacturing (CMC)-Facility

Label is not available on this site.

07/23/1993 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/23/1993 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/23/1993 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/23/1993 SUPPL-10 Labeling

Label is not available on this site.

07/23/1993 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/20/1990 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/12/1989 SUPPL-6 Labeling

Label is not available on this site.

02/05/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/19/1984 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

10/19/1984 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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