Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212384
Company: ENCUBE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.05% 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
11/29/2019 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212384Orig1s000ltr.pdf

TRIAMCINOLONE ACETONIDE

OINTMENT;TOPICAL; 0.05%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.05% OINTMENT;TOPICAL Prescription No AT 213619 CINTEX SVCS
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.05% OINTMENT;TOPICAL Prescription No AT 212384 ENCUBE
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.05% OINTMENT;TOPICAL Prescription No AT 212356 STRIDES PHARMA
TRIAMCINOLONE ACETONIDE IN ABSORBASE TRIAMCINOLONE ACETONIDE 0.05% OINTMENT;TOPICAL Prescription No AT 089595 CMP PHARMA INC

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