U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 206119
Company: ENDO OPERATIONS
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
02/15/2022 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/206119Orig1s000ltr.pdf

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
Back to Top