Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 201011
Company: NOSTRUM LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MORPHINE SULFATE MORPHINE SULFATE 10MG/5ML SOLUTION;ORAL Prescription AA No No
MORPHINE SULFATE MORPHINE SULFATE 20MG/5ML SOLUTION;ORAL Prescription AA No No
MORPHINE SULFATE MORPHINE SULFATE 100MG/5ML SOLUTION;ORAL Prescription AA 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
02/05/2014 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/18/2018 SUPPL-1 REMS - PROPOSAL - D-N-A

Label is not available on this site.

MORPHINE SULFATE

SOLUTION;ORAL; 10MG/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MORPHINE SULFATE MORPHINE SULFATE 10MG/5ML SOLUTION;ORAL Prescription No AA 205509 ANI PHARMS INC
MORPHINE SULFATE MORPHINE SULFATE 10MG/5ML SOLUTION;ORAL Prescription Yes AA 022195 HIKMA
MORPHINE SULFATE MORPHINE SULFATE 10MG/5ML SOLUTION;ORAL Prescription No AA 201011 NOSTRUM LABS INC
MORPHINE SULFATE MORPHINE SULFATE 10MG/5ML SOLUTION;ORAL Prescription No AA 206308 RHODES PHARMS
MORPHINE SULFATE MORPHINE SULFATE 10MG/5ML SOLUTION;ORAL Prescription No AA 203518 TRIS PHARMA INC

SOLUTION;ORAL; 20MG/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MORPHINE SULFATE MORPHINE SULFATE 20MG/5ML SOLUTION;ORAL Prescription No AA 205509 ANI PHARMS INC
MORPHINE SULFATE MORPHINE SULFATE 20MG/5ML SOLUTION;ORAL Prescription Yes AA 022195 HIKMA
MORPHINE SULFATE MORPHINE SULFATE 20MG/5ML SOLUTION;ORAL Prescription No AA 201011 NOSTRUM LABS INC
MORPHINE SULFATE MORPHINE SULFATE 20MG/5ML SOLUTION;ORAL Prescription No AA 206420 RHODES PHARMS
MORPHINE SULFATE MORPHINE SULFATE 20MG/5ML SOLUTION;ORAL Prescription No AA 203519 TRIS PHARMA INC
MORPHINE SULFATE MORPHINE SULFATE 20MG/5ML SOLUTION;ORAL Prescription No AA 201947 VISTAPHARM

SOLUTION;ORAL; 100MG/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MORPHINE SULFATE MORPHINE SULFATE 100MG/5ML SOLUTION;ORAL Prescription No AA 205509 ANI PHARMS INC
MORPHINE SULFATE MORPHINE SULFATE 100MG/5ML SOLUTION;ORAL Prescription No AA 208809 HI TECH
MORPHINE SULFATE MORPHINE SULFATE 100MG/5ML SOLUTION;ORAL Prescription Yes AA 022195 HIKMA
MORPHINE SULFATE MORPHINE SULFATE 100MG/5ML SOLUTION;ORAL Prescription No AA 201011 NOSTRUM LABS INC
MORPHINE SULFATE MORPHINE SULFATE 100MG/5ML SOLUTION;ORAL Prescription No AA 201574 PADDOCK LLC
MORPHINE SULFATE MORPHINE SULFATE 100MG/5ML SOLUTION;ORAL Prescription No AA 206573 PHARM ASSOC
MORPHINE SULFATE MORPHINE SULFATE 100MG/5ML SOLUTION;ORAL Prescription No AA 206308 RHODES PHARMS
MORPHINE SULFATE MORPHINE SULFATE 100MG/5ML SOLUTION;ORAL Prescription No AA 202348 SPECGX LLC
MORPHINE SULFATE MORPHINE SULFATE 100MG/5ML SOLUTION;ORAL Prescription No AA 203518 TRIS PHARMA INC

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