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NADOLOL

ANDA

NADOLOL | A210786 | INGENUS PHARMACEUTICALS LLC

3 strengths0 unique patents0 unique exclusivities

API Supply Chain4 active DMFs1 inactive

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

FERMION OYNADOLOL

DMF 62471986

SIGNA SA DE CVNADOLOL USP

DMF 74261988

MATRIX PHARMACORP PRIVATE LTDNADOLOL USP

DMF 249682011

BIOPHORE INDIA PHARMACEUTICALS PVT LTDNADOLOL

DMF 317352017

SYNCHEM CHEMICALS PRIVATE LTDInactiveNADOLOL

DMF 111921994

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

Products (3)

Sort:

#001 — 20MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 1, 2018

No patent or exclusivity listings for this strength.

#002 — 40MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 1, 2018

#003 — 80MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 1, 2018

Change History (6)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Applicant of nadolol (NDA 210786) changed from Novast Labs to Ingenus Pharms LLC.

Old: NOVAST LABS

New: INGENUS PHARMS LLC

MODIFIEDApplicant Full Name7/1/2026

NADOLOL (nadolol) applicant changed from NOVAST LABORATORIES LTD to INGENUS PHARMACEUTICALS LLC for NDA 210786.

Old: NOVAST LABORATORIES LTD

New: INGENUS PHARMACEUTICALS LLC

MODIFIEDApplicant7/1/2026

Applicant for nadolol NDA 210786 changed from Novast Labs to Ingenus Pharms LLC.

Old: NOVAST LABS

New: INGENUS PHARMS LLC

MODIFIEDApplicant Full Name7/1/2026

Applicant for nadolol (NDA 210786, supplement 003) changed from Novast Laboratories Ltd to Ingenus Pharmaceuticals LLC.

Old: NOVAST LABORATORIES LTD

New: INGENUS PHARMACEUTICALS LLC

MODIFIEDApplicant7/1/2026

Applicant for nadolol (NDA 210786) changed from Novast Labs to Ingenus Pharms LLC.

Old: NOVAST LABS

New: INGENUS PHARMS LLC

MODIFIEDApplicant Full Name7/1/2026

Applicant for nadolol NDA 210786 changed from Novast Laboratories Ltd to Ingenus Pharmaceuticals LLC.

Old: NOVAST LABORATORIES LTD

New: INGENUS PHARMACEUTICALS LLC