Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Saptalis Pharmaceuticals, LLC.
081154447
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Saptalis Pharmaceuticals, LLC.
MICRO LABS LIMITED
Saptalis Pharmaceuticals, LLC.
081154447
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Triamcinolone Acetonide
Product Details
NDC Product Code
42571-385Application Number
ANDA040672Marketing Category
ANDA (C73584)Route of Administration
TOPICALEffective Date
August 10, 2021TriamcinoloneActive
Code: F446C597KAClass: ACTIBQuantity: 1 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YHClass: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1YClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCNClass: IACT
SORBITAN MONOPALMITATEInactive
Code: 77K6Z421KUClass: IACT