Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208201
Company: TARO
Company: TARO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NAFTIFINE HYDROCHLORIDE | NAFTIFINE HYDROCHLORIDE | 2% | 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 |
---|---|---|---|---|---|---|---|
04/10/2019 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208201Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/12/2021 | SUPPL-3 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
10/28/2019 | SUPPL-1 | Labeling-Container/Carton Labels |
Label is not available on this site. |
NAFTIFINE HYDROCHLORIDE
GEL;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% | GEL;TOPICAL | Prescription | No | AB | 208201 | TARO |
NAFTIN | NAFTIFINE HYDROCHLORIDE | 2% | GEL;TOPICAL | Prescription | Yes | AB | 204286 | SEBELA IRELAND LTD |