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FDA Approval

Cyproheptadine Hydrochloride

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

FDA Approval Summary

Company
Effective Date
February 8, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Cyproheptadine(4 mg in 1 1)

Manufacturing Establishments1

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

InvaTech Pharma Solutions LLC

Rising Pharma Holdings, Inc.

078602180

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Cyproheptadine Hydrochloride

Product Details

NDC Product Code
16571-805
Application Number
ANDA207555
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 8, 2022
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Code: NJ82J0F8QCClass: ACTIBQuantity: 4 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
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Cyproheptadine Hydrochloride - FDA Approval | MedPath