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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
Bryant Ranch Prepack
DUNS: 171714327
Effective Date
November 28, 2023
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.

Bryant Ranch Prepack

Bryant Ranch Prepack

171714327

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
71335-1107
Application Number
ANDA209172
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 12, 2018
Code: NJ82J0F8QCClass: ACTIBQuantity: 4 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
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