Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208011
Company: ACTAVIS LABS UT INC
Company: ACTAVIS LABS UT INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AZELAIC ACID | AZELAIC ACID | 15% | 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 |
---|---|---|---|---|---|---|---|
11/19/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/06/2024 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
03/06/2024 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
AZELAIC ACID
GEL;TOPICAL; 15%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AZELAIC ACID | AZELAIC ACID | 15% | GEL;TOPICAL | Prescription | No | AB | 208011 | ACTAVIS LABS UT INC |
AZELAIC ACID | AZELAIC ACID | 15% | GEL;TOPICAL | Prescription | No | AB | 208724 | ENCUBE |
AZELAIC ACID | AZELAIC ACID | 15% | GEL;TOPICAL | Prescription | No | AB | 204637 | GLENMARK PHARMS |
AZELAIC ACID | AZELAIC ACID | 15% | GEL;TOPICAL | Prescription | No | AB | 210549 | TARO |
FINACEA | AZELAIC ACID | 15% | GEL;TOPICAL | Prescription | Yes | AB | 021470 | LEO PHARMA AS |