Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 201574
Company: PADDOCK LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
08/06/2012 ORIG-1 Approval

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-3 REMS - PROPOSAL - D-N-A

Label is not available on this site.

MORPHINE SULFATE

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 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
MORPHINE SULFATE MORPHINE SULFATE 100MG/5ML SOLUTION;ORAL Prescription Yes AA 022195 WEST-WARD PHARMS INT

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