Drugs@FDA: FDA-Approved Drugs
Company: TEVA BRANDED PHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
EMLA | LIDOCAINE; PRILOCAINE | 2.5%;2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM;TOPICAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
12/30/1992 | 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 |
---|---|---|---|---|---|
11/02/2018 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019941s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019941Orig1s021Ltr.pdf | |
01/25/2013 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/27/2006 | SUPPL-18 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019941s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019941s018LTR.pdf | |
12/19/2005 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019941s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019941s017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/019941_S017_EMLA_CREAM.pdf | |
01/27/2003 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19941scp014,015ltr.pdf |
06/02/2000 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/20/2000 | SUPPL-12 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019941_S012_EMLA_CREAM.pdf |
01/28/2000 | SUPPL-11 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/19941S11LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19941S11LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19-941S011.pdf | |
03/11/1999 | SUPPL-10 | Efficacy-Labeling Change With Clinical Data |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/19941s10ltr.pdf |
02/04/1998 | SUPPL-9 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019941s008_emla.pdf |
02/04/1998 | SUPPL-8 | Efficacy-Accelerated Approval Confirmatory Study |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019941s008_emla.pdf |
02/04/1998 | SUPPL-7 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019941s008_emla.pdf |
05/31/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/31/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/27/1995 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/11/1994 | SUPPL-2 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019941_S002_EMLA_CREAM.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/02/2018 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019941s021lbl.pdf | |
04/27/2006 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019941s018lbl.pdf | |
12/19/2005 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019941s017lbl.pdf | |
01/28/2000 | SUPPL-11 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/19941S11LBL.PDF |