Drugs@FDA: FDA-Approved Drugs
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CHLORDIAZEPOXIDE | EQ 12.5MG BASE;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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CHLORDIAZEPOXIDE | EQ 25MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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-Package Insert, Labeling-Medication Guide |
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-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016949s040lbl.pdf | |
12/16/2016 | SUPPL-40 | Labeling-Medication Guide | 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 |