Drugs@FDA: FDA-Approved Drugs
Company: IVAX SUB TEVA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TETRACYCLINE HYDROCHLORIDE | TETRACYCLINE HYDROCHLORIDE | 250MG | CAPSULE;ORAL | Discontinued | None | No | No |
| TETRACYCLINE HYDROCHLORIDE | TETRACYCLINE HYDROCHLORIDE | 500MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 07/05/1963 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/27/2014 | SUPPL-35 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/060704s035lbl.pdf | |
| 06/12/2002 | SUPPL-27 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/12/2001 | SUPPL-26 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/07/2001 | SUPPL-25 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 08/04/2000 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 08/04/2000 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/30/2000 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 01/28/2000 | SUPPL-21 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/30/2000 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/20/1999 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/02/1999 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/02/1999 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/02/1999 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/02/1999 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/02/1999 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/09/1998 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/30/1997 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/04/1996 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/31/1996 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/31/1996 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 01/31/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/30/1996 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/24/1993 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/03/1992 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/03/1992 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/27/1992 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 06/23/1992 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/22/1991 | 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 |
|---|---|---|---|---|---|
| 01/27/2014 | SUPPL-35 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/060704s035lbl.pdf |