Drugs@FDA: FDA-Approved Drugs
Company: ALVOGEN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DEXAMETHASONE | DEXAMETHASONE | 6MG | TABLET;ORAL | Prescription | AB | No | No |
DEXAMETHASONE | DEXAMETHASONE | 0.5MG | TABLET;ORAL | Prescription | BP | No | No |
DEXAMETHASONE | DEXAMETHASONE | 0.75MG | TABLET;ORAL | Prescription | BP | No | No |
DEXAMETHASONE | DEXAMETHASONE | 4MG | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
12/15/1983 | 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 |
---|---|---|---|---|---|
01/14/2022 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
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07/24/2008 | SUPPL-22 | Labeling |
Label is not available on this site. |
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12/06/2002 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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11/26/1997 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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11/26/1997 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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08/12/1997 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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10/30/1995 | SUPPL-16 | Labeling |
Label is not available on this site. |
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04/28/1994 | SUPPL-15 | Labeling |
Label is not available on this site. |
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04/29/1992 | SUPPL-14 | Labeling |
Label is not available on this site. |
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09/18/1990 | SUPPL-13 | Labeling |
Label is not available on this site. |
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01/23/1990 | SUPPL-12 | Labeling |
Label is not available on this site. |
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07/31/1989 | SUPPL-11 | Labeling |
Label is not available on this site. |
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09/16/1988 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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05/01/1986 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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05/01/1986 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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03/26/1984 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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03/26/1984 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
DEXAMETHASONE
TABLET;ORAL; 6MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DEXAMETHASONE | DEXAMETHASONE | 6MG | TABLET;ORAL | Prescription | No | AB | 088481 | ALVOGEN |
DEXAMETHASONE | DEXAMETHASONE | 6MG | TABLET;ORAL | Prescription | No | AB | 215106 | AMNEAL |
DEXAMETHASONE | DEXAMETHASONE | 6MG | TABLET;ORAL | Prescription | No | AB | 217695 | APOTEX |
DEXAMETHASONE | DEXAMETHASONE | 6MG | TABLET;ORAL | Prescription | No | AB | 217001 | BIONPHARMA |
DEXAMETHASONE | DEXAMETHASONE | 6MG | TABLET;ORAL | Prescription | Yes | AB | 088316 | HIKMA |
DEXAMETHASONE | DEXAMETHASONE | 6MG | TABLET;ORAL | Prescription | No | AB | 215604 | NOVITIUM PHARMA |
DEXAMETHASONE | DEXAMETHASONE | 6MG | TABLET;ORAL | Prescription | No | AB | 216282 | ZYDUS PHARMS |
TABLET;ORAL; 4MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DEXAMETHASONE | DEXAMETHASONE | 4MG | TABLET;ORAL | Prescription | No | AB | 088481 | ALVOGEN |
DEXAMETHASONE | DEXAMETHASONE | 4MG | TABLET;ORAL | Prescription | No | AB | 215106 | AMNEAL |
DEXAMETHASONE | DEXAMETHASONE | 4MG | TABLET;ORAL | Prescription | No | AB | 217695 | APOTEX |
DEXAMETHASONE | DEXAMETHASONE | 4MG | TABLET;ORAL | Prescription | No | AB | 217001 | BIONPHARMA |
DEXAMETHASONE | DEXAMETHASONE | 4MG | TABLET;ORAL | Prescription | Yes | AB | 084612 | HIKMA |
DEXAMETHASONE | DEXAMETHASONE | 4MG | TABLET;ORAL | Prescription | No | AB | 215604 | NOVITIUM PHARMA |
DEXAMETHASONE | DEXAMETHASONE | 4MG | TABLET;ORAL | Prescription | No | AB | 080399 | PRASCO |
DEXAMETHASONE | DEXAMETHASONE | 4MG | TABLET;ORAL | Prescription | No | AB | 216282 | ZYDUS PHARMS |