Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019918
Company: MEDTECH PRODUCTS
Company: MEDTECH PRODUCTS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NIX | PERMETHRIN | 1% | LOTION;TOPICAL | Over-the-counter | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
05/02/1990 | ORIG-1 | Approval | Type 8 - Partial Rx to OTC Switch | 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 |
---|---|---|---|---|---|
07/13/2000 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/17/2002 | SUPPL-9 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19918s9ltr.pdf |
04/14/1994 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/13/1993 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/01/1996 | SUPPL-4 | Efficacy-New Indication |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019918ap.pdf |
02/04/1992 | SUPPL-3 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
NIX
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
LOTION;TOPICAL; 1%
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
NIX | PERMETHRIN | 1% | LOTION;TOPICAL | Over-the-counter | Yes | 019918 | MEDTECH PRODUCTS |
PERMETHRIN | PERMETHRIN | 1% | LOTION;TOPICAL | Over-the-counter | No | 075014 | ACTAVIS MID ATLANTIC |
PERMETHRIN | PERMETHRIN | 1% | LOTION;TOPICAL | Over-the-counter | No | 076090 | PERRIGO NEW YORK |