Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087204
Company: LEGACY PHARMA
Company: LEGACY PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CROTAN | CROTAMITON | 10% | LOTION;TOPICAL | Prescription | AT | 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 |
---|---|---|---|---|---|---|---|
12/16/1981 | 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 |
---|---|---|---|---|---|
03/10/2014 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
11/08/1994 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
02/11/1992 | SUPPL-1 | Labeling |
Label is not available on this site. |
CROTAN
LOTION;TOPICAL; 10%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CROTAN | CROTAMITON | 10% | LOTION;TOPICAL | Prescription | No | AT | 087204 | LEGACY PHARMA |
EURAX | CROTAMITON | 10% | LOTION;TOPICAL | Prescription | Yes | AT | 009112 | JOURNEY |