Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076130
Company: DAVA PHARMS INC
Company: DAVA PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VOSPIRE ER | ALBUTEROL SULFATE | EQ 4MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | No | No |
| VOSPIRE ER | ALBUTEROL SULFATE | EQ 8MG BASE | TABLET, EXTENDED 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 |
|---|---|---|---|---|---|---|---|
| 09/30/2002 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076130_ORIGINAL APPROVAL_PACKAGE.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/09/2007 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 08/15/2006 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 01/16/2004 | SUPPL-2 | Labeling |
Label is not available on this site. |
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