Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 204209
Company: LARKEN LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE 325MG;30MG;16MG TABLET;ORAL Prescription None 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
09/30/2016 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204209Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/20/2018 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-7 REMS - PROPOSAL - D-N-A

Label is not available on this site.

11/09/2018 SUPPL-6 Labeling-Container/Carton Labels, Labeling-Proprietary Name Change

Label is not available on this site.

08/29/2017 SUPPL-5 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

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