Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 206506
Company: MYLAN LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NALBUPHINE HYDROCHLORIDE NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE;INJECTION Prescription AP No No
NALBUPHINE HYDROCHLORIDE NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE;INJECTION Prescription AP 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
02/06/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

NALBUPHINE HYDROCHLORIDE

INJECTABLE;INJECTION; 10MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NALBUPHINE HYDROCHLORIDE NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE;INJECTION Prescription No AP 070914 HOSPIRA
NALBUPHINE HYDROCHLORIDE NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE;INJECTION Prescription No AP 070915 HOSPIRA
NALBUPHINE HYDROCHLORIDE NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE;INJECTION Prescription No AP 206506 MYLAN LABS LTD
NALBUPHINE HYDROCHLORIDE NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE;INJECTION Prescription No AP 207595 MYLAN LABS LTD

INJECTABLE;INJECTION; 20MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NALBUPHINE HYDROCHLORIDE NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE;INJECTION Prescription No AP 070916 HOSPIRA
NALBUPHINE HYDROCHLORIDE NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE;INJECTION Prescription No AP 070918 HOSPIRA
NALBUPHINE HYDROCHLORIDE NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE;INJECTION Prescription No AP 206506 MYLAN LABS LTD
NALBUPHINE HYDROCHLORIDE NALBUPHINE HYDROCHLORIDE 20MG/ML INJECTABLE;INJECTION Prescription No AP 207595 MYLAN LABS LTD

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