Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018397
Company: BAYER HEALTHCARE LLC
Company: BAYER HEALTHCARE LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHLOR-TRIMETON | CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE | 8MG;120MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 03/31/1981 | 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 |
|---|---|---|---|---|---|
| 11/09/2001 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/11/2001 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/17/2000 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/26/2001 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/18/2000 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/07/1998 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/22/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/17/1998 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/20/1997 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 01/24/1989 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/08/1986 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/18/1984 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 10/03/1984 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 08/30/1982 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/04/1981 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 05/04/1981 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |