Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019806
Company: ENDO OPERATIONS
Company: ENDO OPERATIONS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SEMPREX-D | ACRIVASTINE; PSEUDOEPHEDRINE HYDROCHLORIDE | 8MG;60MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
03/25/1994 | ORIG-1 | Approval | Type 1 - New Molecular Entity and Type 4 - New Combination | 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 |
---|---|---|---|---|---|
04/11/2018 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019806s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019806Orig1s013ltr.pdf | |
02/25/2004 | SUPPL-8 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19806slr008ltr.pdf |
02/20/2002 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/21/2000 | SUPPL-4 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
12/04/1997 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/30/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/23/1994 | 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 |
---|---|---|---|---|---|
04/11/2018 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019806s013lbl.pdf |