Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Novast Laboratories, Ltd.
527695995
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Novast Laboratories, Ltd.
Northstar Rx LLC
Novast Laboratories, Ltd.
527695995
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Philith
Product Details
NDC Product Code
16714-347Application Number
ANDA090947Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 7, 2017