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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016949
Company: CHARTWELL RX

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIMBITROL AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE EQ 12.5MG BASE;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
LIMBITROL DS AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE EQ 25MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/23/1977 ORIG-1 Approval Type 4 - New Combination 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
01/13/2023 SUPPL-42 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/016949s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/016949Orig1s042ltr.pdf
02/05/2021 SUPPL-41 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/016949s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/016949Orig1s041ltr.pdf
12/16/2016 SUPPL-40 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016949s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016949Orig1s040ltr.pdf
04/25/2016 SUPPL-39 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016949s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016949Orig1s039ltr.pdf
08/03/2007 SUPPL-38 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016949s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016949s038ltr.pdf
01/12/2005 SUPPL-35 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/16949s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/16949s035ltr.pdf
12/19/2001 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.
06/05/2001 SUPPL-33 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16949s33ltr.pdf
03/28/2000 SUPPL-32 Labeling

Label is not available on this site.
03/28/2000 SUPPL-31 Labeling

Label is not available on this site.
12/28/1992 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.
01/16/1990 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.
03/28/2000 SUPPL-27 Labeling

Label is not available on this site.
06/09/1988 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.
11/19/1985 SUPPL-25 Labeling

Label is not available on this site.
04/17/1985 SUPPL-24 Labeling

Label is not available on this site.
06/26/1984 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.
09/20/1982 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.
09/20/1982 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.
03/22/1982 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.
05/19/1980 SUPPL-14 Manufacturing (CMC)-Formulation

Label is not available on this site.
03/28/1980 SUPPL-13 Labeling

Label is not available on this site.
05/19/1980 SUPPL-12 Manufacturing (CMC)-Formulation

Label is not available on this site.
01/21/1980 SUPPL-11 Manufacturing (CMC)-Formulation

Label is not available on this site.
08/15/1979 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.
09/25/1978 SUPPL-9 Labeling

Label is not available on this site.
09/07/1979 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
08/22/1978 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.
07/24/1978 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.
04/17/1978 SUPPL-4 Manufacturing (CMC)-Formulation

Label is not available on this site.
09/09/1980 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.
09/09/1980 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.
09/09/1980 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
01/13/2023 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/016949s042lbl.pdf
02/05/2021 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/016949s041lbl.pdf
12/16/2016 SUPPL-40 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016949s040lbl.pdf
12/16/2016 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016949s040lbl.pdf
04/25/2016 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016949s039lbl.pdf
08/03/2007 SUPPL-38 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016949s038lbl.pdf
01/12/2005 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/16949s035lbl.pdf
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