Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018050
Company: UCB INC
Company: UCB INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CORSYM | CHLORPHENIRAMINE POLISTIREX; PHENYLPROPANOLAMINE POLISTIREX | EQ 4MG MALEATE/5ML;EQ 37.5MG HCL/5ML | SUSPENSION, 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 |
|---|---|---|---|---|---|---|---|
| 01/04/1984 | 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 |
|---|---|---|---|---|---|
| 04/15/1988 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/08/1987 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/19/1987 | SUPPL-6 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 07/28/1986 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/22/1985 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/24/1985 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/16/1984 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |