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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202104
Company: UPSHER SMITH LABS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MORPHINE SULFATE MORPHINE SULFATE 10MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None No Yes
MORPHINE SULFATE MORPHINE SULFATE 20MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
MORPHINE SULFATE MORPHINE SULFATE 30MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
MORPHINE SULFATE MORPHINE SULFATE 50MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
MORPHINE SULFATE MORPHINE SULFATE 60MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
MORPHINE SULFATE MORPHINE SULFATE 80MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
MORPHINE SULFATE MORPHINE SULFATE 100MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/03/2013 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
12/15/2023 SUPPL-23 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
12/15/2021 SUPPL-18 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.
12/15/2021 SUPPL-14 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
12/15/2021 SUPPL-13 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
09/18/2018 SUPPL-11 REMS - MODIFIED - D-N-A

Label is not available on this site.
05/26/2017 SUPPL-9 REMS-Modified

Label is not available on this site.
09/30/2016 SUPPL-7 REMS - MODIFIED - D-N-A

Label is not available on this site.
04/20/2016 SUPPL-6 REMS-Modified

Label is not available on this site.
06/26/2015 SUPPL-5 REMS-Modified

Label is not available on this site.
08/19/2014 SUPPL-4 REMS-Modified

Label is not available on this site.
07/15/2014 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

MORPHINE SULFATE

CAPSULE, EXTENDED RELEASE;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MORPHINE SULFATE MORPHINE SULFATE 20MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202104 UPSHER SMITH LABS

CAPSULE, EXTENDED RELEASE;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 CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202104 UPSHER SMITH LABS

CAPSULE, EXTENDED RELEASE;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MORPHINE SULFATE MORPHINE SULFATE 50MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202104 UPSHER SMITH LABS

CAPSULE, EXTENDED RELEASE;ORAL; 60MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MORPHINE SULFATE MORPHINE SULFATE 60MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202104 UPSHER SMITH LABS

CAPSULE, EXTENDED RELEASE;ORAL; 80MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MORPHINE SULFATE MORPHINE SULFATE 80MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202104 UPSHER SMITH LABS

CAPSULE, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MORPHINE SULFATE MORPHINE SULFATE 100MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202104 UPSHER SMITH LABS
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