Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 207550
Company: AMNEAL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 40MG/ML INJECTABLE;INJECTION Prescription AB 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
12/11/2017 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207550Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/03/2019 SUPPL-3 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

TRIAMCINOLONE ACETONIDE

INJECTABLE;INJECTION; 40MG/ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KENALOG-40 TRIAMCINOLONE ACETONIDE 40MG/ML INJECTABLE;INJECTION Prescription Yes AB 014901 APOTHECON
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 40MG/ML INJECTABLE;INJECTION Prescription No AB 207550 AMNEAL
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 40MG/ML INJECTABLE;INJECTION Prescription No AB 209852 TEVA PHARMS USA

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