Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019855
Company: AUROBINDO PHARMA USA
Company: AUROBINDO PHARMA USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ELIMITE | PERMETHRIN | 5% | CREAM;TOPICAL | Prescription | AB | Yes | 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 |
---|---|---|---|---|---|---|---|
08/25/1989 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
---|---|---|---|---|---|
02/12/2016 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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12/27/2001 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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03/23/2000 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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01/11/2001 | SUPPL-5 | Labeling |
Label is not available on this site. |
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01/30/1995 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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04/14/1994 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/05/1993 | SUPPL-1 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
ELIMITE
CREAM;TOPICAL; 5%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ELIMITE | PERMETHRIN | 5% | CREAM;TOPICAL | Prescription | Yes | AB | 019855 | AUROBINDO PHARMA USA |
PERMETHRIN | PERMETHRIN | 5% | CREAM;TOPICAL | Prescription | No | AB | 074806 | ACTAVIS LABS |
PERMETHRIN | PERMETHRIN | 5% | CREAM;TOPICAL | Prescription | No | AB | 211303 | ENCUBE ETHICALS |
PERMETHRIN | PERMETHRIN | 5% | CREAM;TOPICAL | Prescription | No | AB | 076369 | PADAGIS ISRAEL |