Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204593
Company: CALL INC
Company: CALL INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ADAPALENE | ADAPALENE | 0.1% | SOLUTION;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 |
---|---|---|---|---|---|---|---|
01/05/2016 | 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 |
---|---|---|---|---|---|
07/11/2017 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
ADAPALENE
SOLUTION;TOPICAL; 0.1%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ADAPALENE | ADAPALENE | 0.1% | SOLUTION;TOPICAL | Prescription | No | AB | 203981 | CALL INC |
ADAPALENE | ADAPALENE | 0.1% | SOLUTION;TOPICAL | Prescription | No | AB | 204593 | CALL INC |