Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062733
Company: ACP NIMBLE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MYKACET NYSTATIN; TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;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
03/06/1987 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
05/30/2001 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

12/29/2000 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

04/25/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/07/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/25/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/25/1996 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/25/1996 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/25/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/09/1994 SUPPL-3 Labeling

Label is not available on this site.

09/18/1989 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

MYKACET

OINTMENT;TOPICAL; 100,000 UNITS/GM;0.1%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MYKACET NYSTATIN; TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% OINTMENT;TOPICAL Prescription No AT 062733 ACP NIMBLE
NYSTATIN AND TRIAMCINOLONE ACETONIDE NYSTATIN; TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% OINTMENT;TOPICAL Prescription No AT 207217 AKORN
NYSTATIN AND TRIAMCINOLONE ACETONIDE NYSTATIN; TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% OINTMENT;TOPICAL Prescription No AT 207731 CROWN LABS INC
NYSTATIN AND TRIAMCINOLONE ACETONIDE NYSTATIN; TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% OINTMENT;TOPICAL Prescription No AT 207741 DR REDDYS LABS LTD
NYSTATIN AND TRIAMCINOLONE ACETONIDE NYSTATIN; TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% OINTMENT;TOPICAL Prescription No AT 062602 FOUGERA PHARMS INC
NYSTATIN AND TRIAMCINOLONE ACETONIDE NYSTATIN; TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% OINTMENT;TOPICAL Prescription No AT 208300 GLENMARK PHARMS LTD
NYSTATIN AND TRIAMCINOLONE ACETONIDE NYSTATIN; TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% OINTMENT;TOPICAL Prescription No AT 207380 PERRIGO UK FINCO
NYSTATIN AND TRIAMCINOLONE ACETONIDE NYSTATIN; TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% OINTMENT;TOPICAL Prescription No AT 206785 RISING PHARMS
NYSTATIN AND TRIAMCINOLONE ACETONIDE NYSTATIN; TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% OINTMENT;TOPICAL Prescription No AT 210077 STRIDES PHARMA
NYSTATIN AND TRIAMCINOLONE ACETONIDE NYSTATIN; TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% OINTMENT;TOPICAL Prescription No AT 063305 TARO
NYSTATIN AND TRIAMCINOLONE ACETONIDE NYSTATIN; TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% OINTMENT;TOPICAL Prescription No AT 208287 TELIGENT PHARMA INC

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