Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050582
Company: MAYNE PHARMA INTL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DORYX DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE, DELAYED RELEASE;ORAL Discontinued None Yes No
DORYX DOXYCYCLINE HYCLATE EQ 75MG BASE CAPSULE, DELAYED RELEASE;ORAL Discontinued None 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
07/22/1985 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
02/07/2018 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050582s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050582Orig1s030ltr.pdf
09/02/2015 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/2015/050582s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050582Orig1s029ltr.pdf
03/21/2011 SUPPL-28 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050582s028,050795s013ltr.pdf
02/07/2008 SUPPL-27 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050582s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050582s027ltr.pdf
05/06/2005 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050582s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050582s024ltr.pdf
02/13/2004 SUPPL-22 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50582slr022ltr.pdf
06/05/2003 SUPPL-21 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50582slr021ltr.pdf
10/25/2002 SUPPL-18 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/22/2002 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

06/18/2002 SUPPL-16 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50582s016ltr.pdf
08/13/2001 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

05/04/2001 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

03/15/2001 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

09/01/1999 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/29/1993 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/26/1991 SUPPL-10 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/26/1991 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

05/30/1986 SUPPL-8 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/02/1985 SUPPL-7 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/17/1985 SUPPL-6 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/17/1985 SUPPL-4 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/12/1985 SUPPL-3 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/17/1985 SUPPL-2 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/07/2018 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050582s030lbl.pdf
09/02/2015 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/2015/050582s029lbl.pdf
02/07/2008 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050582s027lbl.pdf
05/06/2005 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050582s024lbl.pdf

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