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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210278
Company: GLENMARK PHARMS LTD

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOPIRAMATE TOPIRAMATE 25MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB2 No No
TOPIRAMATE TOPIRAMATE 50MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB2 No No
TOPIRAMATE TOPIRAMATE 100MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB2 No No
TOPIRAMATE TOPIRAMATE 150MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB2 No No
TOPIRAMATE TOPIRAMATE 200MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB2 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
02/01/2021 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210278Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/07/2023 SUPPL-3 Labeling-Package Insert

Label is not available on this site.
11/21/2022 SUPPL-2 Labeling-Package Insert

Label is not available on this site.
11/21/2022 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

TOPIRAMATE

CAPSULE, EXTENDED RELEASE;ORAL; 25MG
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
QUDEXY XR TOPIRAMATE 25MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB2 205122 UPSHER SMITH LABS
TOPIRAMATE TOPIRAMATE 25MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB2 210278 GLENMARK PHARMS LTD
TOPIRAMATE TOPIRAMATE 25MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB2 208949 ZYDUS

CAPSULE, EXTENDED RELEASE;ORAL; 50MG
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
QUDEXY XR TOPIRAMATE 50MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB2 205122 UPSHER SMITH LABS
TOPIRAMATE TOPIRAMATE 50MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB2 210278 GLENMARK PHARMS LTD
TOPIRAMATE TOPIRAMATE 50MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB2 208949 ZYDUS

CAPSULE, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
QUDEXY XR TOPIRAMATE 100MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB2 205122 UPSHER SMITH LABS
TOPIRAMATE TOPIRAMATE 100MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB2 210278 GLENMARK PHARMS LTD
TOPIRAMATE TOPIRAMATE 100MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB2 208949 ZYDUS

CAPSULE, EXTENDED RELEASE;ORAL; 150MG
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
QUDEXY XR TOPIRAMATE 150MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB2 205122 UPSHER SMITH LABS
TOPIRAMATE TOPIRAMATE 150MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB2 210278 GLENMARK PHARMS LTD
TOPIRAMATE TOPIRAMATE 150MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB2 208949 ZYDUS

CAPSULE, EXTENDED RELEASE;ORAL; 200MG
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
QUDEXY XR TOPIRAMATE 200MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB2 205122 UPSHER SMITH LABS
TOPIRAMATE TOPIRAMATE 200MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB2 210278 GLENMARK PHARMS LTD
TOPIRAMATE TOPIRAMATE 200MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB2 208949 ZYDUS
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