Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071297
Company: MYLAN PHARMS INC
Company: MYLAN PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE | EQ 25MG BASE;10MG | TABLET;ORAL | Prescription | AB | No | Yes |
| CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE | EQ 12.5MG BASE;5MG | TABLET;ORAL | Prescription | AB | No | 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 |
|---|---|---|---|---|---|---|---|
| 12/10/1986 | ORIG-1 | Approval |
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-40 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/06/2022 | SUPPL-38 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 02/05/2021 | SUPPL-36 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/01/2021 | SUPPL-33 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-32 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/25/2016 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/17/2014 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/071297s030lbl.pdf | |
| 02/20/2008 | SUPPL-26 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/071297Orig1s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/071297Orig1s026ltr.pdf | |
| 07/11/2007 | SUPPL-25 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/071297Orig1s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/071297Orig1s025ltr.pdf | |
| 10/06/2005 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 11/07/2000 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 02/05/1998 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1998 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/28/1995 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 05/28/1993 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 09/29/1993 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/31/1994 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 03/31/1994 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/16/1989 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/1989 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 04/26/1989 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/19/1988 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 04/08/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/08/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/13/1987 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/13/1987 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/17/2014 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/071297s030lbl.pdf | |
| 02/20/2008 | SUPPL-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/071297Orig1s026lbl.pdf | |
| 07/11/2007 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/071297Orig1s025lbl.pdf |
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
TABLET;ORAL; EQ 25MG BASE;10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE | EQ 25MG BASE;10MG | TABLET;ORAL | Prescription | No | AB | 211925 | MICRO LABS |
| CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE | EQ 25MG BASE;10MG | TABLET;ORAL | Prescription | No | AB | 071297 | MYLAN PHARMS INC |
TABLET;ORAL; EQ 12.5MG BASE;5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE | EQ 12.5MG BASE;5MG | TABLET;ORAL | Prescription | No | AB | 211925 | MICRO LABS |
| CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE | EQ 12.5MG BASE;5MG | TABLET;ORAL | Prescription | No | AB | 071297 | MYLAN PHARMS INC |