Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090505
Company: IMPAX LABS INC
Company: IMPAX LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 75MG BASE | TABLET, DELAYED RELEASE;ORAL | Discontinued | None | No | No |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 100MG BASE | TABLET, DELAYED RELEASE;ORAL | Discontinued | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 12/28/2010 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090505s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/09/2026 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/09/2026 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/09/2026 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/09/2026 | SUPPL-4 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 11/30/2011 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/30/2011 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |