Drugs@FDA: FDA-Approved Drugs
Company: XANODYNE PHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DARVON COMPOUND | ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE | 389MG;32.4MG;32MG | CAPSULE;ORAL | Discontinued | None | No | No |
DARVON COMPOUND-65 | ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE | 389MG;32.4MG;65MG | CAPSULE;ORAL | Discontinued | None | No | No |
DARVON W/ ASA | ASPIRIN; PROPOXYPHENE HYDROCHLORIDE | 325MG;65MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
11/12/1957 | ORIG-1 | Approval | Type 4 - New Combination | PRIORITY |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/27/2004 | SUPPL-68 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/10996scm068ltr.pdf |
02/24/1999 | SUPPL-65 | Manufacturing (CMC) |
Label is not available on this site. |
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10/05/1998 | SUPPL-64 | Manufacturing (CMC) |
Label is not available on this site. |
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08/10/1998 | SUPPL-63 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/06/1998 | SUPPL-62 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
08/01/2002 | SUPPL-61 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10996slr061,%2010997slr043,%2016862slr033ltr.pdf |
09/15/1992 | SUPPL-60 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
09/02/1994 | SUPPL-58 | Labeling |
Label is not available on this site. |
||
09/15/1992 | SUPPL-57 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/23/1994 | SUPPL-55 | Labeling |
Label is not available on this site. |
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04/16/1987 | SUPPL-48 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/16/1986 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/16/1986 | SUPPL-42 | Labeling |
Label is not available on this site. |
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09/02/1986 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
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04/21/1986 | SUPPL-40 | Labeling |
Label is not available on this site. |
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04/21/1986 | SUPPL-37 | Labeling |
Label is not available on this site. |
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01/28/1985 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/08/1983 | SUPPL-35 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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10/28/1981 | SUPPL-34 | Labeling |
Label is not available on this site. |
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10/28/1981 | SUPPL-33 | Labeling |
Label is not available on this site. |
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05/20/1981 | SUPPL-32 | Labeling |
Label is not available on this site. |
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04/16/1980 | SUPPL-31 | Labeling |
Label is not available on this site. |
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09/26/1979 | SUPPL-30 | Labeling |
Label is not available on this site. |
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07/17/1979 | SUPPL-29 | Labeling |
Label is not available on this site. |
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03/26/1979 | SUPPL-28 | Labeling |
Label is not available on this site. |
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10/13/1978 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
05/26/1978 | SUPPL-26 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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01/18/1980 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/03/1977 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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05/03/1977 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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07/23/1976 | SUPPL-20 | Labeling |
Label is not available on this site. |
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01/06/1975 | SUPPL-14 | Labeling |
Label is not available on this site. |