Last Updated: November 8, 2026

Drug Master Files for: PROPRANOLOL HYDROCHLORIDE

PROPRANOLOL HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
15849	A	II	2/1/2002	IPCA LABORATORIES LTD	PROPRANOLOL HYDROCHLORIDE USP
2265	I	II	4/25/1974	AYERST LABORATORIES INC	DEXPROPRANOLOL INJ
2968	I	II	6/24/1977	ACIC LTD	PROPRANOLOL HCL USP XIX
33222	A	II	10/30/2018	LUPIN LTD	PROPRANOLOL HYDROCHLORIDE USP
3565	I	II	7/6/1979	INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE SPA	PROPRANOLOL HCL.
3663	I	II	11/27/1979	INDUSTRIA CHEMICA PRODOTTI FRANCIS SPA	PROPRANOLOL HCL
4104	A	II	2/27/1981	COSMA SPA	PROPRANOLOL HCL
>DMF No.	>Status	>Type	>Submission Date	>Holder	>Subject

Drug Master File Glossary

STATUS OF DMFS

A = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date.
I = Inactive
N = Not an assigned number
P = DMF Pending Filing Review

TYPES OF DMFs

Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
Type III Packaging Material
Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
Type V FDA Accepted Reference Information

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