Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078592
Company: TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARBAMAZEPINE CARBAMAZEPINE 100MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
CARBAMAZEPINE CARBAMAZEPINE 200MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
CARBAMAZEPINE CARBAMAZEPINE 300MG CAPSULE, EXTENDED RELEASE;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
09/20/2012 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
01/20/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

01/20/2015 SUPPL-2 Labeling-Container/Carton Labels

Label is not available on this site.

CARBAMAZEPINE

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

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

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