Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019589
Company: SCHERING
Company: SCHERING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VANCENASE AQ | BECLOMETHASONE DIPROPIONATE MONOHYDRATE | EQ 0.042MG DIPROP/SPRAY | SPRAY, METERED;NASAL | 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 |
---|---|---|---|---|---|---|---|
12/23/1987 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
---|---|---|---|---|---|
08/30/2000 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/15/1995 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
09/02/1993 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/02/1993 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/15/1988 | SUPPL-1 | Labeling |
Label is not available on this site. |