Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Morton Grove Pharmaceuticals, Inc.
801897505
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Morton Grove Pharmaceuticals, Inc.
Morton Grove Pharmaceuticals, Inc.
Morton Grove Pharmaceuticals, Inc.
801897505
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Megestrol Acetate
Product Details
NDC Product Code
60432-126Application Number
ANDA076721Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
June 10, 2020Megestrol acetateActive
Code: TJ2M0FR8ESClass: ACTIBQuantity: 40 mg in 1 mL
POLOXAMER 124Inactive
Code: 1S66E28KXAClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT