Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074278
Company: SENTYNL THERAPS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVORPHANOL TARTRATE LEVORPHANOL TARTRATE 2MG TABLET;ORAL Prescription AB No Yes
LEVORPHANOL TARTRATE LEVORPHANOL TARTRATE 1MG TABLET;ORAL Discontinued None No No
LEVORPHANOL TARTRATE LEVORPHANOL TARTRATE 3MG TABLET;ORAL Prescription None 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
03/31/2000 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/74278ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/074278.PDF
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/21/2018 SUPPL-13 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-12 REMS - PROPOSAL - D-N-A

Label is not available on this site.

06/18/2018 SUPPL-11 Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/074278Orig1s011ltredt.pdf
12/16/2016 SUPPL-9 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

07/16/2008 SUPPL-5 Labeling

Label is not available on this site.

04/08/2005 SUPPL-3 Labeling

Label is not available on this site.

09/05/2000 SUPPL-1 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

LEVORPHANOL TARTRATE

TABLET;ORAL; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVORPHANOL TARTRATE LEVORPHANOL TARTRATE 2MG TABLET;ORAL Prescription No AB 074278 SENTYNL THERAPS INC
LEVORPHANOL TARTRATE LEVORPHANOL TARTRATE 2MG TABLET;ORAL Prescription No AB 211484 VIRTUS PHARMS

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