Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040248
Company: CHARTWELL

• REMS

Products on ANDA 040248

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;7.5MG	TABLET;ORAL	Discontinued	None	No	No
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;10MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040248

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/28/2000	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40248ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/040248.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/02/2024	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/02/2024	SUPPL-9	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/04/2021	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/11/2019	SUPPL-7	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/21/2018	SUPPL-6	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/18/2018	SUPPL-5	REMS - PROPOSAL - D-N-A		Label is not available on this site.
12/16/2016	SUPPL-4	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/16/2016	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
11/02/2015	SUPPL-1	Labeling-Package Insert		Label is not available on this site.