Drugs@FDA: FDA-Approved Drugs
Company: BAYER HEALTHCARE LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHLOR-TRIMETON | CHLORPHENIRAMINE MALEATE | 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| CHLOR-TRIMETON | CHLORPHENIRAMINE MALEATE | 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 08/15/1950 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
|---|---|---|---|---|---|
| 12/23/2015 | SUPPL-38 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/007638Orig1s038ltr.pdf |
| 02/04/2008 | SUPPL-33 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/007638s033ltr.pdf |
| 01/19/2006 | SUPPL-32 | Manufacturing (CMC)-Formulation |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/007638s032ltr.pdf |
| 03/06/2002 | SUPPL-29 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 01/26/2001 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/19/2000 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/17/1998 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/20/1997 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 07/08/1986 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/30/1986 | SUPPL-22 | Efficacy-Rx To OTC Switch |
Label is not available on this site. |
||
| 09/18/1984 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/30/1986 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 02/18/1983 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/04/1983 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 08/30/1982 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/07/1982 | SUPPL-13 | Efficacy-Rx To OTC Switch |
Label is not available on this site. |
||
| 10/30/1981 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 06/11/1980 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/30/1980 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/03/1980 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/01/1980 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/20/1979 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 01/05/1979 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/18/1978 | SUPPL-2 | Labeling |
Label is not available on this site. |