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PROPRANOLOL HYDROCHLORIDE

ANDA

PROPRANOLOL HYDROCHLORIDE | A078022 | CHARTWELL RX SCIENCES LLC

4 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.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 23, 2007	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 60MG

0 patents0 exclusivities▴

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Feb 15, 2007

No patent or exclusivity listings for this strength.

#002 — 80MG

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Feb 15, 2007

#003 — 120MG

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Feb 15, 2007

#004 — 160MG

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Feb 15, 2007

Change History (8)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Chartwell RX acquired the NDA for propranolol hydrochloride (NDA 078022, Supplement 004) from Extrovis.

Old: EXTROVIS

New: CHARTWELL RX

MODIFIEDApplicant7/1/2026

Chartwell Rx acquired NDA 078022 for propranolol hydrochloride from Extrovis, replacing the previous applicant of record.

Old: EXTROVIS

New: CHARTWELL RX

MODIFIEDApplicant Full Name7/1/2026

Applicant for propranolol hydrochloride NDA 078022 changed from EXTROVIS AG to CHARTWELL RX SCIENCES LLC.

Old: EXTROVIS AG

New: CHARTWELL RX SCIENCES LLC

MODIFIEDApplicant Full Name7/1/2026

Applicant for propranolol hydrochloride (NDA 078022-003) changed from EXTROVIS AG to CHARTWELL RX SCIENCES LLC.

Old: EXTROVIS AG

New: CHARTWELL RX SCIENCES LLC

MODIFIEDApplicant7/1/2026

Chartwell Rx became the listed applicant for propranolol hydrochloride (NDA 078022), replacing Extrovis.

Old: EXTROVIS

New: CHARTWELL RX

MODIFIEDApplicant Full Name7/1/2026

CHARTWELL RX SCIENCES LLC replaced EXTROVIS AG as the applicant for propranolol hydrochloride (NDA 078022).

Old: EXTROVIS AG

New: CHARTWELL RX SCIENCES LLC

MODIFIEDApplicant7/1/2026

Chartwell Rx became the listed applicant for propranolol hydrochloride (NDA 078022, supplement 003), replacing Extrovis.

Old: EXTROVIS

New: CHARTWELL RX

MODIFIEDApplicant Full Name7/1/2026

Applicant for propranolol hydrochloride NDA 078022 changed from Extrovis AG to Chartwell Rx Sciences LLC.

Old: EXTROVIS AG

New: CHARTWELL RX SCIENCES LLC