Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018066
Company: CHATTEM
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
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
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.

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

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

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