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FDA Approval

Progesterone

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
October 23, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Progesterone(200 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

RPK Pharmaceuticals, Inc.

RPK Pharmaceuticals, Inc.

147096275

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
53002-2760
Application Number
ANDA205229
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
June 6, 2022
Code: 4G7DS2Q64YClass: ACTIBQuantity: 200 mg in 1 1
PEANUT OILInactive
Code: 5TL50QU0W4Class: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7UClass: IACT
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