Tolvaptan
These highlights do not include all the information needed to use TOLVAPTAN TABLETS safely and effectively. See full prescribing information for TOLVAPTAN TABLETS. TOLVAPTAN tablets, for oral use Initial U.S. Approval: 2009
dd71ee70-9435-4715-bee5-edbb5a8d7d7b
HUMAN PRESCRIPTION DRUG LABEL
Sep 7, 2022
Ascend Laboratories, LLC
DUNS: 141250469
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tolvaptan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (8)
Tolvaptan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (8)
Tolvaptan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (8)
Drug Labeling Information
INFORMATION FOR PATIENTS SECTION
17 PATIENT COUNSELING INFORMATION
As a part of patient counseling, healthcare providers must review the tolvaptan tablets Medication Guide with every patient [see FDA-Approved Medication Guide].
Pregnancy
Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to inform their prescriber of a known or suspected pregnancy [see Use in Specific Populations (8.1)].
Lactation
Advise patients not to breastfeed an infant if they are taking tolvaptan tablets [see Use in Specific Populations (8.2)].
** Manufactured by:**
Alkem Laboratories Ltd.,
INDIA.
Distributed by:
Ascend Laboratories, LLC
Parsippany, NJ 07054
Revised: May, 2022