Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Bryant Ranch Prepack
171714327
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Bryant Ranch Prepack
Bryant Ranch Prepack
Bryant Ranch Prepack
171714327
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Progesterone
Product Details
NDC Product Code
71335-1432Application Number
ANDA207724Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
July 14, 2023ProgesteroneActive
Code: 4G7DS2Q64YClass: ACTIBQuantity: 200 mg in 1 1
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62Class: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
PEANUT OILInactive
Code: 5TL50QU0W4Class: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT