Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074471
Company: DR REDDYS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NALBUPHINE HYDROCHLORIDE NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE;INJECTION Discontinued None No No
NALBUPHINE HYDROCHLORIDE NALBUPHINE HYDROCHLORIDE 20MG/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
03/19/1998 ORIG-1 Approval Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74471.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/09/2019 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

04/23/1999 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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