Drugs@FDA: FDA-Approved Drugs
Company: TEVA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROCORTISONE | HYDROCORTISONE | 100MG/60ML | ENEMA;RECTAL | 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 |
---|---|---|---|---|---|---|---|
05/27/1994 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/17/2008 | SUPPL-23 | Labeling |
Label is not available on this site. |
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07/09/2002 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/31/2001 | SUPPL-14 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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10/31/2001 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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10/31/2001 | SUPPL-12 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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01/04/2002 | SUPPL-11 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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01/23/2002 | SUPPL-10 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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01/04/2002 | SUPPL-9 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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02/26/2001 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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02/15/2000 | SUPPL-7 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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02/15/2000 | SUPPL-6 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
03/23/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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06/25/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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05/31/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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11/20/1995 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |