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 | AB | 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. |
VOSPIRE ER
TABLET, EXTENDED RELEASE;ORAL; EQ 4MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 4MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078092 | MYLAN |
VOSPIRE ER | ALBUTEROL SULFATE | EQ 4MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076130 | DAVA PHARMS INC |
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