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PROPRANOLOL HYDROCHLORIDE

ANDA

PROPRANOLOL HYDROCHLORIDE | A070690 | HIKMA PHARMACEUTICALS USA INC

2 strengths0 unique patents0 unique exclusivities

API Supply Chain7 active DMFs6 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

SIMS SRLPROPRANOLOL HYDROCHLORIDE

DMF 51391983

W R GRACE AND CO -CONNPROPRANOLOL HYDROCHLORIDE

DMF 58611985

IPCA LABORATORIES LTDPROPRANOLOL HYDROCHLORIDE USP

DMF 158492002

MANKIND PHARMA LTDPROPRANOLOL HYDROCHLORIDE USP

DMF 356352021

MACLEODS PHARMACEUTICALS LTDPROPRANOLOL HYDROCHLORIDE USP

DMF 397522024

ALIVUS LIFE SCIENCES LTDPROPRANOLOL HYDROCHLORIDE USP

DMF 397822024

RAKS PHARMA PVT LTDPROPRANOLOL HYDROCHLORIDE USP

DMF 423982025

LUSOCHIMICA SPAInactivePROPRANOLOL HYDROCHLORIDE USP XX, NF XV

DMF 49821983

UNIQUE PHARMACEUTICAL LABORATORIES A DIV OF JB CHEMICALS AND PHARMACEUTICALS LTDInactivePROPRANOLOL HYDROCHLORIDE (U.S.P.)

DMF 53251984

KOTHARI PHYTOCHEMICALS INTERNATIONALInactivePROPRANOLOL HYDROCHLORIDE

DMF 59371985

BOEHRINGER KNOLL LTDInactivePROPRANOLOL HYDROCHLORIDE

DMF 83091989

CYANAMID UK LTDInactivePROPRANOLOL HYDROCHLORIDE

DMF 93121991

LUPIN LTDInactivePROPRANOLOL HYDROCHLORIDE USP

DMF 332222018

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (2)

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#001 — 40MG/5ML

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: May 15, 1987

No patent or exclusivity listings for this strength.

#002 — 20MG/5ML

0 patents0 exclusivities▾

SOLUTION;ORAL | Approved: May 15, 1987

Change History (1)

Recent changes detected for this application.

MODIFIEDTE Code7/1/2026

Hikma's propranolol hydrochloride product (NDA 070690) received a therapeutic equivalence rating of AA, indicating bioequivalence to the reference standard.

New: AA