Drugs@FDA: FDA-Approved Drugs
Company: KANCHAN HLTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DEXAMETHASONE | DEXAMETHASONE | 0.5MG/5ML | ELIXIR;ORAL | Prescription | AA | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
09/21/1976 | 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 |
---|---|---|---|---|---|
06/05/2024 | SUPPL-61 | Labeling-Package Insert |
Label is not available on this site. |
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10/02/2000 | SUPPL-51 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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10/27/1995 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
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06/02/1995 | SUPPL-47 | Labeling |
Label is not available on this site. |
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05/25/1994 | SUPPL-45 | Labeling |
Label is not available on this site. |
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07/20/1992 | SUPPL-44 | Labeling |
Label is not available on this site. |
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05/31/1991 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
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05/02/1991 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
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09/28/1990 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
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01/04/1990 | SUPPL-39 | Labeling |
Label is not available on this site. |
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10/28/1991 | SUPPL-38 | Labeling |
Label is not available on this site. |
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04/05/1990 | SUPPL-37 | Labeling |
Label is not available on this site. |
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02/08/1989 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
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02/08/1989 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
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02/08/1989 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
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03/28/1989 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
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05/13/1988 | SUPPL-32 | Labeling |
Label is not available on this site. |
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09/01/1982 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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10/08/1982 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
DEXAMETHASONE
ELIXIR;ORAL; 0.5MG/5ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DEXAMETHASONE | DEXAMETHASONE | 0.5MG/5ML | ELIXIR;ORAL | Prescription | No | AA | 091188 | CHARTWELL MOLECULAR |
DEXAMETHASONE | DEXAMETHASONE | 0.5MG/5ML | ELIXIR;ORAL | Prescription | No | AA | 084754 | KANCHAN HLTHCARE |
DEXAMETHASONE | DEXAMETHASONE | 0.5MG/5ML | ELIXIR;ORAL | Prescription | No | AA | 090891 | LYNE |