Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076514
Company: CHARTWELL RX
Company: CHARTWELL RX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Discontinued | None | No | No |
| MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Discontinued | None | No | No |
| MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 10MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 09/11/2003 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076514.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/27/2010 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/02/2004 | SUPPL-3 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076514s001,002,003.pdf | |
| 07/02/2004 | SUPPL-2 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076514s001,002,003.pdf |
| 07/02/2004 | SUPPL-1 | Manufacturing (CMC)-New Strength |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076514s001,002,003.pdf |