Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 205758
Company: EUROHLTH INTL SARL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MORPHINE SULFATE MORPHINE SULFATE 4MG/ML INJECTABLE;INJECTION Prescription AP No No
MORPHINE SULFATE MORPHINE SULFATE 8MG/ML INJECTABLE;INJECTION Prescription AP No No
MORPHINE SULFATE MORPHINE SULFATE 10MG/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
05/21/2015 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205758Orig1s000ltr.pdf

MORPHINE SULFATE

INJECTABLE;INJECTION; 4MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MORPHINE SULFATE MORPHINE SULFATE 4MG/ML INJECTABLE;INJECTION Prescription No AP 205758 EUROHLTH INTL SARL
MORPHINE SULFATE MORPHINE SULFATE 4MG/ML INJECTABLE;INJECTION Prescription Yes AP 202515 HOSPIRA INC

INJECTABLE;INJECTION; 8MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MORPHINE SULFATE MORPHINE SULFATE 8MG/ML INJECTABLE;INJECTION Prescription No AP 205758 EUROHLTH INTL SARL
MORPHINE SULFATE MORPHINE SULFATE 8MG/ML INJECTABLE;INJECTION Prescription Yes AP 202515 HOSPIRA INC

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INFUMORPH MORPHINE SULFATE 10MG/ML INJECTABLE;INJECTION Prescription Yes AP 018565 WEST-WARD PHARMS INT
MITIGO MORPHINE SULFATE 10MG/ML INJECTABLE;INJECTION Prescription No AP 204393 PIRAMAL CRITICAL
MORPHINE SULFATE MORPHINE SULFATE 10MG/ML INJECTABLE;INJECTION Prescription No AP 205758 EUROHLTH INTL SARL
MORPHINE SULFATE MORPHINE SULFATE 10MG/ML INJECTABLE;INJECTION Prescription Yes AP 202515 HOSPIRA INC

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