Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 020712
Company: SHIRE DEV LLC
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
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 REMS-Proposal, Labeling 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
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 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020712s031lbl.pdf
01/26/2011 SUPPL-31 Labeling 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 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 SHIRE DEV LLC

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 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 SHIRE DEV LLC

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 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 SHIRE DEV LLC

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English