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DOXYCYCLINE

ANDA

DOXYCYCLINE | A065055 | STRIDES PHARMA INTERNATIONAL AG

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: MONODOX(TE code: AB)

API Supply Chain8 active DMFs8 inactive

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

HOVIONE FARMACIENCIA SADOXYCYCLINE MONOHYDRATE

DMF 137101998

YANGZHOU LIBERTY PHARMACEUTICAL CO LTDDOXYCYCLINE MONOHYDRATE

DMF 139441999

CHANGZHOU PHARMACEUTICAL FACTORYDOXYCYCLINE

DMF 189592005

HOVIONE FARMACIENCIA SADOXYCYCLINE MONOHYDRATE MICRONIZED

DMF 236382010

RAKS PHARMA PVT LTDDOXYCYCLINE USP

DMF 250622011

RAKS PHARMA PVT LTDDOXYCYCLINE HYCLATE, USP

DMF 259552012

CHANGZHOU PHARMACEUTICAL FACTORYDOXYCYCLINE (ROUTE CODE: DX)

DMF 392922023

MAITHRI DRUGS PRIVATE LTDDOXYCYCLINE MONOHYDRATE USP

DMF 418462025

CHEMWERTH INCInactiveDOXYCYCLINE MONOHYDRATE

DMF 72811988

HENAN KAIFENG PHARMACEUTICAL FACTORYInactiveDOXYCYCLINE HYDROCHLORIDE

DMF 128641998

KUNSHAN ORIENTAL PHARMACEUTICAL CO LTDInactiveDOXYCYCLINE USP, NON-STERILE BULK DRUG

DMF 130401998

ANKERMAN SPAInactiveDOXYCYCLINE

DMF 134501998

WATSON LABORATORIES INCInactiveDOXYCYCLINE

DMF 135001998

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveDOXYCYCLINE USP

DMF 142951999

HENAN KAIFENG PHARMACEUTICAL FACTORYInactiveDOXYCYCLINE HYDROCHLORIDE

DMF 170942004

HUASHU PHARMACEUTICAL CORPInactiveDOXYCYCLINE MONOHYDRATE

DMF 183132005

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jul 24, 2014	SUPPL -13	View Letter (PDF)
Dec 1, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — EQ 50MG BASE

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Dec 1, 2000

No patent or exclusivity listings for this strength.

#002 — EQ 100MG BASE

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Dec 1, 2000

#003 — EQ 150MG BASE

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jul 15, 2005

#004 — EQ 75MG BASE

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Apr 18, 2005