Drugs@FDA: FDA-Approved Drugs
Company: ACTAVIS MID ATLANTIC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROCORTISONE | HYDROCORTISONE | 2.5% | CREAM;TOPICAL | Prescription | AT | 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 |
---|---|---|---|---|---|---|---|
03/10/1988 | 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 |
---|---|---|---|---|---|
12/13/2001 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/11/2001 | SUPPL-18 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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07/11/2001 | SUPPL-17 | Labeling |
Label is not available on this site. |
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07/11/2001 | SUPPL-16 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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07/11/2001 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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04/26/2001 | SUPPL-14 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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12/29/2000 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/30/1999 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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11/20/1998 | SUPPL-11 | Labeling |
Label is not available on this site. |
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11/20/1998 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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11/20/1998 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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12/21/1998 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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09/13/1996 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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09/13/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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09/13/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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09/13/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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11/10/1994 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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11/10/1994 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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11/10/1994 | SUPPL-1 | Labeling |
Label is not available on this site. |
HYDROCORTISONE
CREAM;TOPICAL; 2.5%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ALA-CORT | HYDROCORTISONE | 2.5% | CREAM;TOPICAL | Prescription | No | AT | 080706 | CROWN LABS |
ANUSOL HC | HYDROCORTISONE | 2.5% | CREAM;TOPICAL | Prescription | No | AT | 088250 | SALIX PHARMS |
HYDROCORTISONE | HYDROCORTISONE | 2.5% | CREAM;TOPICAL | Prescription | No | AT | 089682 | ACTAVIS MID ATLANTIC |
HYDROCORTISONE | HYDROCORTISONE | 2.5% | CREAM;TOPICAL | Prescription | No | AT | 089414 | FOUGERA PHARMS INC |
HYDROCORTISONE | HYDROCORTISONE | 2.5% | CREAM;TOPICAL | Prescription | No | AT | 085025 | PADAGIS US |
HYDROCORTISONE | HYDROCORTISONE | 2.5% | CREAM;TOPICAL | Prescription | No | AT | 040879 | RISING |
HYDROCORTISONE | HYDROCORTISONE | 2.5% | CREAM;TOPICAL | Prescription | No | AT | 088799 | TARO |