Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 200812
Company: PAR PHARM INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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 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
11/10/2011 ORIG-1 Approval Not Applicable Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/200812Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/18/2018 SUPPL-13 REMS - MODIFIED - D-N-A

Label is not available on this site.

05/26/2017 SUPPL-11 REMS-Modified

Label is not available on this site.

09/30/2016 SUPPL-10 REMS - MODIFIED - D-N-A

Label is not available on this site.

04/20/2016 SUPPL-8 REMS-Modified

Label is not available on this site.

06/26/2015 SUPPL-6 REMS-Modified

Label is not available on this site.

08/19/2014 SUPPL-5 REMS-Modified

Label is not available on this site.

02/06/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

04/24/2013 SUPPL-2 Labeling-Medication Guide, 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
KADIAN MORPHINE SULFATE 20MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 020616 ALLERGAN
MORPHINE SULFATE MORPHINE SULFATE 20MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 200411 IMPAX LABS INC
MORPHINE SULFATE MORPHINE SULFATE 20MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 200812 PAR PHARM INC
MORPHINE SULFATE MORPHINE SULFATE 20MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202718 TEVA PHARMS USA
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
KADIAN MORPHINE SULFATE 30MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 020616 ALLERGAN
MORPHINE SULFATE MORPHINE SULFATE 30MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 200411 IMPAX LABS INC
MORPHINE SULFATE MORPHINE SULFATE 30MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 200812 PAR PHARM INC
MORPHINE SULFATE MORPHINE SULFATE 30MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202718 TEVA PHARMS USA
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
KADIAN MORPHINE SULFATE 50MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 020616 ALLERGAN
MORPHINE SULFATE MORPHINE SULFATE 50MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 200411 IMPAX LABS INC
MORPHINE SULFATE MORPHINE SULFATE 50MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 200812 PAR PHARM INC
MORPHINE SULFATE MORPHINE SULFATE 50MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202718 TEVA PHARMS USA
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
KADIAN MORPHINE SULFATE 60MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 020616 ALLERGAN
MORPHINE SULFATE MORPHINE SULFATE 60MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 200411 IMPAX LABS INC
MORPHINE SULFATE MORPHINE SULFATE 60MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 200812 PAR PHARM INC
MORPHINE SULFATE MORPHINE SULFATE 60MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202718 TEVA PHARMS USA
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
KADIAN MORPHINE SULFATE 80MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 020616 ALLERGAN
MORPHINE SULFATE MORPHINE SULFATE 80MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 200411 IMPAX LABS INC
MORPHINE SULFATE MORPHINE SULFATE 80MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 200812 PAR PHARM INC
MORPHINE SULFATE MORPHINE SULFATE 80MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202718 TEVA PHARMS USA
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
KADIAN MORPHINE SULFATE 100MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 020616 ALLERGAN
MORPHINE SULFATE MORPHINE SULFATE 100MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 200411 IMPAX LABS INC
MORPHINE SULFATE MORPHINE SULFATE 100MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 200812 PAR PHARM INC
MORPHINE SULFATE MORPHINE SULFATE 100MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202718 TEVA PHARMS USA
MORPHINE SULFATE MORPHINE SULFATE 100MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202104 UPSHER SMITH LABS

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