Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210038
Company: XIROMED
Company: XIROMED
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NAFTIFINE HYDROCHLORIDE | NAFTIFINE HYDROCHLORIDE | 2% | CREAM;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 |
|---|---|---|---|---|---|---|---|
| 09/22/2020 | 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 |
|---|---|---|---|---|---|
| 10/06/2022 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
NAFTIFINE HYDROCHLORIDE
CREAM;TOPICAL; 2%
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| NAFTIFINE HYDROCHLORIDE | NAFTIFINE HYDROCHLORIDE | 2% | CREAM;TOPICAL | Prescription | No | AB | 206960 | AMNEAL |
| NAFTIFINE HYDROCHLORIDE | NAFTIFINE HYDROCHLORIDE | 2% | CREAM;TOPICAL | Prescription | No | AB | 206901 | TARO |
| NAFTIFINE HYDROCHLORIDE | NAFTIFINE HYDROCHLORIDE | 2% | CREAM;TOPICAL | Prescription | No | AB | 210038 | XIROMED |
| NAFTIN | NAFTIFINE HYDROCHLORIDE | 2% | CREAM;TOPICAL | Prescription | Yes | AB | 019599 | SEBELA IRELAND LTD |