Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050582
Company: MAYNE PHARMA
Company: MAYNE PHARMA
| 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 |
|---|---|---|---|---|---|
| 03/02/2020 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050582s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050582Orig1s031ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 03/02/2020 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050582s031lbl.pdf | |
| 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 |