Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Direct Rx
079254320
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Direct Rx
Direct Rx
Direct Rx
079254320
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
72189-347Application Number
ANDA205229Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
April 27, 2022MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7UClass: IACT
ProgesteroneActive
Code: 4G7DS2Q64YClass: ACTIBQuantity: 200 mg in 1 1
PEANUT OILInactive
Code: 5TL50QU0W4Class: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62Class: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT