Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203887
Company: NOSTRUM LABS INC
Company: NOSTRUM LABS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DAPSONE | DAPSONE | 25MG | TABLET;ORAL | Prescription | AB | No | No |
DAPSONE | DAPSONE | 100MG | 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 |
---|---|---|---|---|---|---|---|
05/06/2016 | ORIG-1 | Approval |
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 |
TABLET;ORAL; 100MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DAPSONE | DAPSONE | 100MG | TABLET;ORAL | Prescription | No | AB | 204380 | ACTAVIS LLC |
DAPSONE | DAPSONE | 100MG | TABLET;ORAL | Prescription | Yes | AB | 086842 | EVEREST LIFE SCI |
DAPSONE | DAPSONE | 100MG | TABLET;ORAL | Prescription | No | AB | 203887 | NOSTRUM LABS INC |
DAPSONE | DAPSONE | 100MG | TABLET;ORAL | Prescription | No | AB | 206505 | NOVITIUM PHARMA |
DAPSONE | DAPSONE | 100MG | TABLET;ORAL | Prescription | No | AB | 207165 | RISING |