Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201000
Company: ACTAVIS MID ATLANTIC
Company: ACTAVIS MID ATLANTIC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ADAPALENE | ADAPALENE | 0.3% | 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 |
---|---|---|---|---|---|---|---|
10/27/2014 | ORIG-1 | Approval | Not Applicable |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201000Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/11/2023 | SUPPL-6 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
ADAPALENE
GEL;TOPICAL; 0.3%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ADAPALENE | ADAPALENE | 0.3% | GEL;TOPICAL | Prescription | No | AB | 201000 | ACTAVIS MID ATLANTIC |
ADAPALENE | ADAPALENE | 0.3% | GEL;TOPICAL | Prescription | No | AB | 213508 | ALEMBIC |
ADAPALENE | ADAPALENE | 0.3% | GEL;TOPICAL | Prescription | No | AB | 200298 | ENCUBE ETHICALS |
ADAPALENE | ADAPALENE | 0.3% | GEL;TOPICAL | Prescription | No | AB | 208322 | TARO |
DIFFERIN | ADAPALENE | 0.3% | GEL;TOPICAL | Prescription | Yes | AB | 021753 | GALDERMA LABS LP |