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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207605
Company: APOTEX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOLVAPTAN TOLVAPTAN 30MG TABLET;ORAL Prescription AB No No
TOLVAPTAN TOLVAPTAN 15MG TABLET;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
09/06/2022 ORIG-2 Approval STANDARD

Label is not available on this site.

05/19/2020 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207605Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/08/2022 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

TOLVAPTAN

TABLET;ORAL; 30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SAMSCA TOLVAPTAN 30MG TABLET;ORAL Prescription Yes AB 022275 OTSUKA
TOLVAPTAN TOLVAPTAN 30MG TABLET;ORAL Prescription No AB 211891 ALKEM LABS LTD
TOLVAPTAN TOLVAPTAN 30MG TABLET;ORAL Prescription No AB 207605 APOTEX
TOLVAPTAN TOLVAPTAN 30MG TABLET;ORAL Prescription No AB 205646 HETERO LABS LTD V
TOLVAPTAN TOLVAPTAN 30MG TABLET;ORAL Prescription No AB 206119 PAR PHARM INC

TABLET;ORAL; 15MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SAMSCA TOLVAPTAN 15MG TABLET;ORAL Prescription Yes AB 022275 OTSUKA
TOLVAPTAN TOLVAPTAN 15MG TABLET;ORAL Prescription No AB 211891 ALKEM LABS LTD
TOLVAPTAN TOLVAPTAN 15MG TABLET;ORAL Prescription No AB 207605 APOTEX
TOLVAPTAN TOLVAPTAN 15MG TABLET;ORAL Prescription No AB 205646 HETERO LABS LTD V
TOLVAPTAN TOLVAPTAN 15MG TABLET;ORAL Prescription No AB 206119 PAR PHARM INC
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