Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020712
Company: TAKEDA PHARMS USA
Company: TAKEDA PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARBATROL | CARBAMAZEPINE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| CARBATROL | CARBAMAZEPINE | 300MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | Yes |
| CARBATROL | CARBAMAZEPINE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 09/30/1997 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020712_carbatrol_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/11/2023 | SUPPL-38 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020712s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020712Orig1s038ltr.pdf | |
| 12/01/2021 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020712s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020712Orig1s037ltr.pdf | |
| 08/26/2018 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020712s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020712Orig1s036ltr.pdf | |
| 03/22/2013 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020712s032s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020712Orig1s032,s035ltr.pdf | |
| 08/22/2011 | SUPPL-34 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020712s034ltr.pdf |
| 03/22/2013 | SUPPL-32 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020712s032s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020712Orig1s032,s035ltr.pdf | |
| 01/26/2011 | SUPPL-31 | Labeling, REMS-Proposal |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020712s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020712s031ltr.pdf | |
| 04/23/2009 | SUPPL-30 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020712s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020712s030ltr.pdf | |
| 12/11/2007 | SUPPL-29 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020712s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020712s029ltr.pdf | |
| 06/30/2006 | SUPPL-25 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020712s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020712s025LTR.pdf | |
| 01/24/2006 | SUPPL-24 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020712s024ltr.pdf |
| 08/07/2002 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/21/2002 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/30/2001 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/08/2000 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/08/2000 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/17/2001 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/14/2000 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/19/2000 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/08/1999 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/22/1999 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/28/1999 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/28/1999 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/27/1999 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/27/1999 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/24/1998 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/11/2023 | SUPPL-38 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020712s038lbl.pdf | |
| 04/11/2023 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020712s038lbl.pdf | |
| 12/01/2021 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020712s037lbl.pdf | |
| 08/26/2018 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020712s036lbl.pdf | |
| 03/22/2013 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020712s032s035lbl.pdf | |
| 03/22/2013 | SUPPL-32 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020712s032s035lbl.pdf | |
| 01/26/2011 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020712s031lbl.pdf | |
| 01/26/2011 | SUPPL-31 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020712s031lbl.pdf | |
| 04/23/2009 | SUPPL-30 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020712s030lbl.pdf | |
| 12/11/2007 | SUPPL-29 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020712s029lbl.pdf | |
| 06/30/2006 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020712s025lbl.pdf |
CARBATROL
CAPSULE, EXTENDED RELEASE;ORAL; 200MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078986 | APOTEX INC |
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076697 | NOSTRUM LABS INC |
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201106 | TARO |
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078592 | TEVA PHARMS |
| CARBATROL | CARBAMAZEPINE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 020712 | TAKEDA PHARMS USA |
CAPSULE, EXTENDED RELEASE;ORAL; 300MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARBAMAZEPINE | CARBAMAZEPINE | 300MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078986 | APOTEX INC |
| CARBAMAZEPINE | CARBAMAZEPINE | 300MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076697 | NOSTRUM LABS INC |
| CARBAMAZEPINE | CARBAMAZEPINE | 300MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201106 | TARO |
| CARBAMAZEPINE | CARBAMAZEPINE | 300MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078592 | TEVA PHARMS |
| CARBATROL | CARBAMAZEPINE | 300MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 020712 | TAKEDA PHARMS USA |
CAPSULE, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARBAMAZEPINE | CARBAMAZEPINE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078986 | APOTEX INC |
| CARBAMAZEPINE | CARBAMAZEPINE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076697 | NOSTRUM LABS INC |
| CARBAMAZEPINE | CARBAMAZEPINE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201106 | TARO |
| CARBAMAZEPINE | CARBAMAZEPINE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078592 | TEVA PHARMS |
| CARBATROL | CARBAMAZEPINE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 020712 | TAKEDA PHARMS USA |