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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216949
Company: MSN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOLVAPTAN TOLVAPTAN 15MG TABLET;ORAL Prescription AB No No
TOLVAPTAN TOLVAPTAN 30MG 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
06/21/2023 ORIG-1 Approval STANDARD

Label is not available on this site.

TOLVAPTAN

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 206119 ENDO OPERATIONS
TOLVAPTAN TOLVAPTAN 15MG TABLET;ORAL Prescription No AB 205646 HETERO LABS LTD V
TOLVAPTAN TOLVAPTAN 15MG TABLET;ORAL Prescription No AB 216949 MSN

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 206119 ENDO OPERATIONS
TOLVAPTAN TOLVAPTAN 30MG TABLET;ORAL Prescription No AB 205646 HETERO LABS LTD V
TOLVAPTAN TOLVAPTAN 30MG TABLET;ORAL Prescription No AB 216949 MSN
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