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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214044
Company: ATHENA

Medication Guide

REMS

Products on NDA 214044

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
QDOLO	TRAMADOL HYDROCHLORIDE	5MG/ML	SOLUTION;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 214044

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/01/2020	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214044s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/214044Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214044Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/22/2025	SUPPL-4	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/214044s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/214044Orig1s004ltr.pdf
10/31/2024	SUPPL-3	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/214044Orig1s003ltr.pdf
12/15/2023	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214044s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214044Orig1s002ltr.pdf
09/10/2021	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214044s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214044Orig1s001ltr.pdf

Labels for NDA 214044

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/22/2025	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/214044s004lbl.pdf
12/22/2025	SUPPL-4	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/214044s004lbl.pdf
12/15/2023	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214044s002lbl.pdf
09/10/2021	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214044s001lbl.pdf
09/01/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214044s000lbl.pdf

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