Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 210610
Company: UPSHER SMITH LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MORPHINE SULFATE MORPHINE SULFATE 15MG TABLET;ORAL Prescription AB No No
MORPHINE SULFATE MORPHINE SULFATE 30MG TABLET;ORAL Prescription AB 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
07/22/2019 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210610Orig1s000ltr.pdf

MORPHINE SULFATE

TABLET;ORAL; 15MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MORPHINE SULFATE MORPHINE SULFATE 15MG TABLET;ORAL Prescription Yes AB 022207 HIKMA
MORPHINE SULFATE MORPHINE SULFATE 15MG TABLET;ORAL Prescription No AB 210610 UPSHER SMITH LABS

TABLET;ORAL; 30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MORPHINE SULFATE MORPHINE SULFATE 30MG TABLET;ORAL Prescription Yes AB 022207 HIKMA
MORPHINE SULFATE MORPHINE SULFATE 30MG TABLET;ORAL Prescription No AB 210610 UPSHER SMITH LABS

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