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FDA Approval

Methadone 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
December 27, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Methadone(5 mg in 1 1)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Bryant Ranch Prepack

171714327

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

Bryant Ranch Prepack

171714327

Products1

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

Methadone Hydrochloride

Product Details

NDC Product Code
71335-0493
Application Number
ANDA203502
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
March 4, 2021
MethadoneActive
Code: 229809935BClass: ACTIBQuantity: 5 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
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