Drugs@FDA: FDA-Approved Drugs
Company: BAYER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| QUINAGLUTE | QUINIDINE GLUCONATE | 324MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 12/08/1969 | 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 |
|---|---|---|---|---|---|
| 04/26/2001 | SUPPL-39 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 11/14/2000 | SUPPL-38 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 03/31/1999 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/24/2000 | SUPPL-36 | Labeling |
Label is not available on this site. |
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| 07/01/1998 | SUPPL-35 | Labeling |
Label is not available on this site. |
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| 11/16/1995 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/17/1995 | SUPPL-33 | Labeling |
Label is not available on this site. |
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| 06/30/1987 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/14/1987 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/14/1989 | SUPPL-29 | Labeling |
Label is not available on this site. |
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| 07/14/1986 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/30/1985 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/02/1984 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/23/1984 | SUPPL-24 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 01/23/1984 | SUPPL-23 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 01/23/1984 | SUPPL-22 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 04/07/1982 | SUPPL-21 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 04/07/1981 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/1981 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/25/1981 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/27/1980 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/27/1979 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/27/1979 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/24/1979 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/25/1979 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/02/1978 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/25/1978 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/06/1977 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/06/1977 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/06/1977 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 10/06/1977 | SUPPL-4 | Unspecified |
Label is not available on this site. |