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MIDODRINE HYDROCHLORIDE

ANDA

MIDODRINE HYDROCHLORIDE | A207613 | UNIQUE PHARMACEUTICAL LABORATORIES A DIV OF JB CHEMICALS AND PHARMACEUTICALS LTD

3 strengths0 unique patents0 unique exclusivities

API Supply Chain13 active DMFs3 inactive

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

INDUSTRIALE CHIMICA SRLMIDODRINE HYDROCHLORIDE

DMF 160062002

EDMOND PHARMA SRLMIDODRINE HYDROCHLORIDE

DMF 160172002

STERLING WISCONSIN LLCMIDODRINE HYDROCHLORIDE USP

DMF 164812003

APOTEX INCMIDODRINE HYDROCHLORIDE USP

DMF 184702005

IPCA LABORATORIES LTDMIDODRINE HYDROCHLORIDE USP

DMF 274642013

PH HEALTH LTDMIDODRINE HYDROCHLORIDE USP

DMF 282112014

TIANJIN WEIJIE PHARMACEUTICAL CO LTDMIDODRINE HYDROCHLORIDE BULK DRUG SUBSTANCE

DMF 302162016

ENALTEC LABS PRIVATE LTDMIDODRINE HYDROCHLORIDE USP

DMF 308062016

EMCURE PHARMACEUTICALS LTDMIDODRINE HYDROCHLORIDE USP

DMF 309902016

OPTIMUS DRUGS PRIVATE LTDMIDODRINE HYDROCHLORIDE

DMF 362722021

ZYDUS LIFESCIENCES LTDMIDODRINE HYDROCHLORIDE USP

DMF 378652022

DASAMI LAB PRIVATE LTDMIDODRINE HYDROCHLORIDE USP

DMF 398852024

MANKIND PHARMA LTDMIDODRINE HYDROCHLORIDE USP

DMF 404082024

NYCOMED AUSTRIA GMBHInactiveMIDODRINE HYDROCHLORIDE

DMF 63151986

CADILA HEALTHCARE LTDInactiveMIDODRINE HYDROCHLORIDE

DMF 156102001

CHEMAGIS LTDInactiveMIDODRINE HYDROCHLORIDE

DMF 164172003

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

Products (3)

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#001 — 2.5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 2, 2018

No patent or exclusivity listings for this strength.

#002 — 5MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 2, 2018

#003 — 10MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 2, 2018