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CARBAMAZEPINE از شرکت NOSTRUM LABS INC

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CARBAMAZEPINE از شرکت NOSTRUM LABS INC

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
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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