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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
June 15, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Progesterone(100 mg in 1 1)

Manufacturing Establishments1

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

NuCare Pharmaceuticals,Inc.

NuCare Pharmaceuticals,Inc.

010632300

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
68071-2768
Application Number
ANDA205229
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
June 15, 2023
PEANUT OILInactive
Code: 5TL50QU0W4Class: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7UClass: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62Class: IACT
Code: 4G7DS2Q64YClass: ACTIBQuantity: 100 mg in 1 1
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