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Drugs@FDA: FDA-Approved Drugs

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

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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 PHARMS LTD
DOXYCYCLINE DOXYCYCLINE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 204446 COSETTE
DOXYCYCLINE DOXYCYCLINE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 204234 LUPIN LTD
DOXYCYCLINE DOXYCYCLINE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 209396 MAYNE PHARMA INC
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 204446 COSETTE
DOXYCYCLINE DOXYCYCLINE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 204234 LUPIN LTD
DOXYCYCLINE DOXYCYCLINE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 209396 MAYNE PHARMA INC
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 PHARMS LTD
DOXYCYCLINE DOXYCYCLINE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 204446 COSETTE
DOXYCYCLINE DOXYCYCLINE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 204234 LUPIN LTD
DOXYCYCLINE DOXYCYCLINE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 209396 MAYNE PHARMA INC
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
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