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MINOCYCLINE HYDROCHLORIDE

ANDA

MINOCYCLINE HYDROCHLORIDE | A065005 | IMPAX LABORATORIES INC

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: MINOCIN(TE code: AB)

API Supply Chain9 active DMFs7 inactive

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

HOVIONE FARMACIENCIA SAMINOCYCLINE HYDROCHLORIDE

DMF 137381998

CIPAN - COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS SAMINOCYCLINE HYDROCHLORIDE

DMF 137581998

CURIA ITALY SRLMINOCYCLINE HYDROCHLORIDE (DIHYDRATE)

DMF 148022000

IDT AUSTRALIA LTDMINOCYCLINE HYDROCHLORIDE USP

DMF 150142000

ZHEJIANG HISUN PHARMACEUTICAL CO LTDMINOCYCLINE HYDROCHLORIDE USP

DMF 260502012

HOVIONE FARMACIENCIA SAMINOCYCLINE HYDROCHLORIDE MICRONIZED

DMF 290032015

ZHEJIANG MEDICINE CO LTDMINOCYCLINE HYDROCHLORIDE

DMF 326642018

CURIA ITALY SRLMINOCYCLINE HYDROCHLORIDE (DIHYDRATE) MICRONIZED

DMF 332792018

ZHEJIANG CHANGHAI PHARMACEUTICALS CO LTDMINOCYCLINE HYDROCHLORIDE USP

DMF 359392022

PARKE DAVIS AND COInactiveMINOCYCLINE HYDROCHLORIDE CAP

DMF 24081975

FINE CHEMICALS CORPInactiveMINOCYCLINE HYDROCHLORIDE

DMF 71991987

LEDERLE LABORATORIESInactiveMINOCYCLINE HYDROCHLORIDE

DMF 134041998

NIPPON KAYAKU CO LTDInactiveMINOCYCLINE HYDROCHLORIDE

DMF 137481998

KYOWA HAKKO KOGYO CO LTDInactiveMINOCYCLINE HYDROCHLORIDE

DMF 137551998

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)InactiveMINOCYCLINE HYDROCHLORIDE USP

DMF 151712000

HOVIONE FARMACIENCIA SAInactiveMINOCYCLINE

DMF 342172019

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 23, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

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#001 — EQ 50MG BASE

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Mar 23, 1999

No patent or exclusivity listings for this strength.

#002 — EQ 100MG BASE

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Mar 23, 1999

#003 — EQ 75MG BASE

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Apr 18, 2001