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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076697
Company: NOSTRUM LABS INC

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
05/20/2011 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/076697Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/076697Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/29/2024 SUPPL-17 Labeling-Medication Guide, Labeling-Patient Package Insert

Label is not available on this site.
11/09/2022 SUPPL-16 Labeling-Package Insert

Label is not available on this site.
11/09/2022 SUPPL-12 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
11/09/2022 SUPPL-7 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.
02/18/2015 SUPPL-4 Labeling-Medication Guide, Labeling-Package Insert

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 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

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
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