Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086841
Company: EVEREST LIFE SCI
Company: EVEREST LIFE SCI
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DAPSONE | DAPSONE | 25MG | TABLET;ORAL | Prescription | AB | Yes | 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 |
---|---|---|---|---|---|---|---|
07/03/1979 | 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 |
---|---|---|---|---|---|
08/24/2009 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
08/14/1992 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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07/13/1988 | SUPPL-13 | Labeling |
Label is not available on this site. |
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07/13/1988 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/13/1988 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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07/13/1988 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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12/02/1983 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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05/05/1982 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/05/1982 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
DAPSONE
TABLET;ORAL; 25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DAPSONE | DAPSONE | 25MG | TABLET;ORAL | Prescription | No | AB | 204380 | ACTAVIS LLC |
DAPSONE | DAPSONE | 25MG | TABLET;ORAL | Prescription | Yes | AB | 086841 | EVEREST LIFE SCI |
DAPSONE | DAPSONE | 25MG | TABLET;ORAL | Prescription | No | AB | 203887 | NOSTRUM LABS INC |
DAPSONE | DAPSONE | 25MG | TABLET;ORAL | Prescription | No | AB | 206505 | NOVITIUM PHARMA |
DAPSONE | DAPSONE | 25MG | TABLET;ORAL | Prescription | No | AB | 207165 | RISING |