Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018066
Company: CHATTEM

Products on NDA 018066

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
UNISOM	DOXYLAMINE SUCCINATE	25MG	TABLET;ORAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018066

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/18/1978	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/01/2022	SUPPL-21	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018066Orig1s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/018066Orig1s021ltr.pdf
09/12/2013	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018066Orig1s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018066Orig1s020ltr.pdf
12/20/2002	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
05/30/2002	SUPPL-13	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18066s011ltr.pdf
04/26/2002	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
05/30/2002	SUPPL-11	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18066s011ltr.pdf
08/24/1984	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
05/30/1989	SUPPL-9	Manufacturing (CMC)-Formulation		Label is not available on this site.
02/23/1984	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
03/11/1983	SUPPL-7	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/12/1987	SUPPL-6	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
08/05/1982	SUPPL-5	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
08/05/1982	SUPPL-4	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
12/21/1981	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
08/31/1981	SUPPL-2	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
02/13/1978	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.

Labels for NDA 018066

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/01/2022	SUPPL-21	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018066Orig1s021lbl.pdf
09/12/2013	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018066Orig1s020lbl.pdf

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

UNISOM

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET;ORAL; 25MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
DOXYLAMINE SUCCINATE	DOXYLAMINE SUCCINATE	25MG	TABLET;ORAL	Over-the-counter	No	040564	LNK
DOXYLAMINE SUCCINATE	DOXYLAMINE SUCCINATE	25MG	TABLET;ORAL	Over-the-counter	No	040167	PERRIGO
UNISOM	DOXYLAMINE SUCCINATE	25MG	TABLET;ORAL	Over-the-counter	Yes	018066	CHATTEM