Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 050641
Company: CHARTWELL RX

Products on NDA 050641

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MONODOX	DOXYCYCLINE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	AB	Yes	No
MONODOX	DOXYCYCLINE	EQ 50MG BASE	CAPSULE;ORAL	Prescription	AB	Yes	No
MONODOX	DOXYCYCLINE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	AB	Yes	No
MONODOX	DOXYCYCLINE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	AB	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050641

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/29/1989	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/08/2024	SUPPL-33	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050641s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/050641Orig1s033ltr.pdf
02/17/2022	SUPPL-32	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050641Orig1s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050641Orig1s032ltr.pdf
04/03/2017	SUPPL-29	Labeling-Package Insert	Label (PDF) Letter (PDF)	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050641s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050641Orig1s029ltr.pdf
08/05/2016	SUPPL-28	Manufacturing (CMC)		Label is not available on this site.
10/11/2013	SUPPL-27	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050641s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050641Orig1s027ltr.pdf
03/08/2011	SUPPL-26	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050641s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050641s026ltr.pdf
01/11/2012	SUPPL-18	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050641s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050641s018ltr.pdf
12/20/2007	SUPPL-14	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050641s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050641s014ltr.pdf
01/31/2007	SUPPL-13	Labeling-Container/Carton Labels, Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050641s013ltr.pdf
06/18/2002	SUPPL-10	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50641s010ltr.pdf
03/21/2002	SUPPL-8	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50641s8ltr.pdf
01/07/1994	SUPPL-7	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
06/24/1992	SUPPL-6	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/06/1992	SUPPL-5	Labeling		Label is not available on this site.
11/15/1991	SUPPL-4	Labeling		Label is not available on this site.
02/10/1992	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
09/25/1991	SUPPL-2	Manufacturing (CMC)-Packaging		Label is not available on this site.
11/15/1991	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 050641

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/08/2024	SUPPL-33	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050641s033lbl.pdf
02/17/2022	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050641Orig1s032lbl.pdf
04/03/2017	SUPPL-29	Labeling-Package Insert	Label (PDF)	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050641s029lbl.pdf
10/11/2013	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050641s027lbl.pdf
01/11/2012	SUPPL-18	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050641s018lbl.pdf
03/08/2011	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050641s026lbl.pdf
12/20/2007	SUPPL-14	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050641s014lbl.pdf

Therapeutic Equivalents for NDA 050641

MONODOX

CAPSULE;ORAL; EQ 100MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	No	AB	209165	ALEMBIC
DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	No	AB	209396	DR REDDYS LABS SA
DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	No	AB	204234	LUPIN LTD
DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	No	AB	065055	STRIDES PHARMA
DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	No	AB	065053	SUN PHARM INDS LTD
DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	No	AB	205115	ZYDUS PHARMS
MONODOX	DOXYCYCLINE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	050641	CHARTWELL RX

CAPSULE;ORAL; EQ 50MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOXYCYCLINE	DOXYCYCLINE	EQ 50MG BASE	CAPSULE;ORAL	Prescription	No	AB	209396	DR REDDYS LABS SA
DOXYCYCLINE	DOXYCYCLINE	EQ 50MG BASE	CAPSULE;ORAL	Prescription	No	AB	204234	LUPIN LTD
DOXYCYCLINE	DOXYCYCLINE	EQ 50MG BASE	CAPSULE;ORAL	Prescription	No	AB	065055	STRIDES PHARMA
DOXYCYCLINE	DOXYCYCLINE	EQ 50MG BASE	CAPSULE;ORAL	Prescription	No	AB	065053	SUN PHARM INDS LTD
DOXYCYCLINE	DOXYCYCLINE	EQ 50MG BASE	CAPSULE;ORAL	Prescription	No	AB	205115	ZYDUS PHARMS
MONODOX	DOXYCYCLINE	EQ 50MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	050641	CHARTWELL RX

CAPSULE;ORAL; EQ 75MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOXYCYCLINE	DOXYCYCLINE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	No	AB	209165	ALEMBIC
DOXYCYCLINE	DOXYCYCLINE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	No	AB	209396	DR REDDYS LABS SA
DOXYCYCLINE	DOXYCYCLINE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	No	AB	204234	LUPIN LTD
DOXYCYCLINE	DOXYCYCLINE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	No	AB	065053	SUN PHARM INDS LTD
DOXYCYCLINE	DOXYCYCLINE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	No	AB	205115	ZYDUS PHARMS
MONODOX	DOXYCYCLINE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	050641	CHARTWELL RX

CAPSULE;ORAL; EQ 150MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOXYCYCLINE	DOXYCYCLINE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	No	AB	065055	STRIDES PHARMA
MONODOX	DOXYCYCLINE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	050641	CHARTWELL RX