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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

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
03/31/2025 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/050641s034lbl.pdf
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
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