Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085691
Company: FOUGERA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.025% OINTMENT;TOPICAL Prescription AT No No
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.5% OINTMENT;TOPICAL Prescription AT No No
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.1% OINTMENT;TOPICAL Prescription AT 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
03/09/1978 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
08/23/2004 SUPPL-35 Labeling

Label is not available on this site.

03/07/1996 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

12/30/1994 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

05/20/1988 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

03/25/1988 SUPPL-30 Labeling

Label is not available on this site.

07/31/1987 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

05/20/1988 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

09/25/1986 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

05/04/1983 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

05/04/1983 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

10/28/1982 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

07/27/1982 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

07/27/1982 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

07/27/1982 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

07/27/1982 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/27/1982 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

TRIAMCINOLONE ACETONIDE

OINTMENT;TOPICAL; 0.025%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TRIAMCINOLONE ACETATE TRIAMCINOLONE ACETONIDE 0.025% OINTMENT;TOPICAL Prescription No AT 209828 MACLEODS PHARMS LTD
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.025% OINTMENT;TOPICAL Prescription No AT 089795 ACP NIMBLE
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.025% OINTMENT;TOPICAL Prescription No AT 085691 FOUGERA PHARMS
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.025% OINTMENT;TOPICAL Prescription No AT 087385 PERRIGO NEW YORK

OINTMENT;TOPICAL; 0.5%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TRIAMCINOLONE ACETATE TRIAMCINOLONE ACETONIDE 0.5% OINTMENT;TOPICAL Prescription No AT 209828 MACLEODS PHARMS LTD
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.5% OINTMENT;TOPICAL Prescription No AT 208925 ACP NIMBLE
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.5% OINTMENT;TOPICAL Prescription No AT 085691 FOUGERA PHARMS
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.5% OINTMENT;TOPICAL Prescription No AT 206379 GLENMARK PHARMS LTD
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.5% OINTMENT;TOPICAL Prescription No AT 087385 PERRIGO NEW YORK
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.5% OINTMENT;TOPICAL Prescription No AT 208590 TELIGENT PHARMA INC

OINTMENT;TOPICAL; 0.1%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TRIAMCINOLONE ACETATE TRIAMCINOLONE ACETONIDE 0.1% OINTMENT;TOPICAL Prescription No AT 209828 MACLEODS PHARMS LTD
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.1% OINTMENT;TOPICAL Prescription No AT 089796 ACP NIMBLE
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.1% OINTMENT;TOPICAL Prescription No AT 085691 FOUGERA PHARMS
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.1% OINTMENT;TOPICAL Prescription No AT 208320 GLENMARK PHARMS
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.1% OINTMENT;TOPICAL Prescription No AT 207365 NOVEL LABS INC
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.1% OINTMENT;TOPICAL Prescription No AT 087385 PERRIGO NEW YORK
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.1% OINTMENT;TOPICAL Prescription No AT 040037 TARO PHARM INDS LTD
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.1% OINTMENT;TOPICAL Prescription No AT 205373 TELIGENT PHARMA INC

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