Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074917
Company: DR REDDYS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FENTANYL CITRATE PRESERVATIVE FREE FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE;INJECTION Discontinued None 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
02/03/1998 ORIG-1 Approval Review (PDF)

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https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74917ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/08/2000 SUPPL-1 Manufacturing (CMC)-Control

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