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NEBIVOLOL HYDROCHLORIDE

ANDA

NEBIVOLOL HYDROCHLORIDE | A212661 | MACLEODS PHARMACEUTICALS LTD

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: BYSTOLIC(TE code: AB)

API Supply Chain13 active DMFs1 inactive

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

CADILA PHARMACEUTICALS LTDNEBIVOLOL HYDROCHLORIDE

DMF 211522007

FIS FABBRICA ITALIANA SINTETICI SPANEBIVOLOL HYDROCHLORIDE

DMF 227352009

TORRENT PHARMACEUTICALS LTDNEBIVOLOL HYDROCHLORIDE

DMF 229062009

MSN PHARMACHEM PRIVATE LTDNEBIVOLOL HYDROCHLORIDE [ROUTE CODE: 'NH']

DMF 249162011

HETERO DRUGS LTDNEBIVOLOL HYDROCHLORIDE

DMF 252962011

HONOUR LAB LTDNEBIVOLOL HYDROCHLORIDE

DMF 286272014

ZHEJIANG AUSUN PHARMACEUTICAL CO LTDNEBIVOLOL HYDROCHLORIDE

DMF 297302015

MACLEODS PHARMACEUTICALS LTDNEBIVOLOL HYDROCHLORIDE

DMF 299962016

CORDEN PHARMA CHENOVENEBIVOLOL HYDROCHLORIDE

DMF 300522015

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDNEBIVOLOL HYDROCHLORIDE

DMF 308482016

HETERO DRUGS LTDNEBIVOLOL HYDROCHLORIDE (PROCESS-II)

DMF 310812016

SMAART PHARMACEUTTICALSNEBIVOLOL HYDROCHLORIDE

DMF 353322021

ALKEM LABORATORIES LTDNEBIVOLOL HYDROCHLORIDE

DMF 393132024

DR REDDYS LABORATORIES LTDInactiveNEBIVOLOL HYDROCHLORIDE

DMF 248212011

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

Products (4)

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#001 — EQ 2.5MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jan 28, 2025

No patent or exclusivity listings for this strength.

#002 — EQ 5MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jan 28, 2025

#003 — EQ 10MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jan 28, 2025

#004 — EQ 20MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jan 28, 2025