Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Banner Pharmacaps
002193829
Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Banner Pharmacaps
Banner Pharmacaps
Banner Pharmacaps
945494508
Pharmacia and Upjohn Company
Banner Pharmacaps
Banner Pharmacaps
829076566
Products2
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
10888-7136Application Number
ANDA200900Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 22, 2013FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
ProgesteroneActive
Code: 4G7DS2Q64YClass: ACTIBQuantity: 200 mg in 1 1
GELATINInactive
Code: 2G86QN327LClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62Class: IACT
PEANUT OILInactive
Code: 5TL50QU0W4Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
PROGESTERONE
Product Details
NDC Product Code
10888-7135Application Number
ANDA200900Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 22, 2013LECITHIN, SOYBEANInactive
Code: 1DI56QDM62Class: IACT
ProgesteroneActive
Code: 4G7DS2Q64YClass: ACTIBQuantity: 100 mg in 1 1
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
PEANUT OILInactive
Code: 5TL50QU0W4Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT