Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040285
Company: IVAX SUB TEVA PHARMS
Company: IVAX SUB TEVA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE | HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE | 1.5MG/5ML;5MG/5ML | SYRUP;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 |
|---|---|---|---|---|---|---|---|
| 07/19/1999 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40285ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/08/2002 | SUPPL-6 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 11/02/2001 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/18/2000 | SUPPL-4 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/18/2000 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/18/2000 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/18/2000 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |