Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 208653
Company: KVK TECH INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
APADAZ ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE 325MG;EQ 6.12MG BASE TABLET;ORAL Prescription None Yes No
APADAZ ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE 325MG;EQ 4.08MG BASE TABLET;ORAL Prescription None Yes No
APADAZ ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE 325MG;EQ 8.16MG BASE TABLET;ORAL Prescription None Yes 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
02/23/2018 ORIG-1 Approval Type 4 - New Combination PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208653s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208653Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208653Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/07/2019 SUPPL-5 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208653s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208653Orig1s005ltr.pdf
09/18/2018 SUPPL-3 REMS - PROPOSAL - D-N-A Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208653s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208653Orig1s002s003ltr.pdf
09/18/2018 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208653s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208653Orig1s002s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/07/2019 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208653s005lbl.pdf
10/07/2019 SUPPL-5 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208653s005lbl.pdf
09/18/2018 SUPPL-3 REMS - PROPOSAL - D-N-A Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208653s002s003lbl.pdf
09/18/2018 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208653s002s003lbl.pdf
02/23/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208653s000lbl.pdf

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