Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091526
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE DIPHENHYDRAMINE HYDROCHLORIDE 50MG/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
03/26/2013 ORIG-1 Approval Not Applicable Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/091526lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/26/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/091526lbl.pdf

DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE

INJECTABLE;INJECTION; 50MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription No AP 040466 APP PHARMS
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription No AP 040140 HOSPIRA
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription No AP 205723 MICRO LABS
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription No AP 040498 MYLAN INSTITUTIONAL
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription No AP 080817 WEST-WARD PHARMS INT
DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription No AP 091526 FRESENIUS KABI USA

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