Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212701
Company: AMNEAL
Company: AMNEAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DAPSONE | DAPSONE | 7.5% | GEL;TOPICAL | 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 |
---|---|---|---|---|---|---|---|
05/31/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
DAPSONE
GEL;TOPICAL; 7.5%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ACZONE | DAPSONE | 7.5% | GEL;TOPICAL | Prescription | Yes | AB | 207154 | ALMIRALL |
DAPSONE | DAPSONE | 7.5% | GEL;TOPICAL | Prescription | No | AB | 215718 | ALEMBIC |
DAPSONE | DAPSONE | 7.5% | GEL;TOPICAL | Prescription | No | AB | 212701 | AMNEAL |
DAPSONE | DAPSONE | 7.5% | GEL;TOPICAL | Prescription | No | AB | 213847 | MYLAN |
DAPSONE | DAPSONE | 7.5% | GEL;TOPICAL | Prescription | No | AB | 210191 | TARO |
DAPSONE | DAPSONE | 7.5% | GEL;TOPICAL | Prescription | No | AB | 214722 | TORRENT |