Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076453
Company: FOUGERA PHARMS
Company: FOUGERA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LIDOCAINE AND PRILOCAINE | LIDOCAINE; PRILOCAINE | 2.5%;2.5% | CREAM;TOPICAL | Prescription | AB | No | 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 |
---|---|---|---|---|---|---|---|
08/18/2003 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076453.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/21/2004 | SUPPL-5 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076453s001s002s003s004s005.pdf |
07/21/2004 | SUPPL-4 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076453s001s002s003s004s005.pdf | |
07/21/2004 | SUPPL-3 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076453s001s002s003s004s005.pdf | |
01/21/2004 | SUPPL-2 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076453s001s002s003s004s005.pdf | |
06/14/2004 | SUPPL-1 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076453s001s002s003s004s005.pdf |
LIDOCAINE AND PRILOCAINE
CREAM;TOPICAL; 2.5%;2.5%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LIDOCAINE AND PRILOCAINE | LIDOCAINE; PRILOCAINE | 2.5%;2.5% | CREAM;TOPICAL | Prescription | No | AB | 213923 | ALEMBIC |
LIDOCAINE AND PRILOCAINE | LIDOCAINE; PRILOCAINE | 2.5%;2.5% | CREAM;TOPICAL | Prescription | No | AB | 076320 | ENCUBE |
LIDOCAINE AND PRILOCAINE | LIDOCAINE; PRILOCAINE | 2.5%;2.5% | CREAM;TOPICAL | Prescription | No | AB | 076453 | FOUGERA PHARMS |
LIDOCAINE AND PRILOCAINE | LIDOCAINE; PRILOCAINE | 2.5%;2.5% | CREAM;TOPICAL | Prescription | No | AB | 212482 | PADAGIS US |
LIDOCAINE AND PRILOCAINE | LIDOCAINE; PRILOCAINE | 2.5%;2.5% | CREAM;TOPICAL | Prescription | No | AB | 205887 | PAI HOLDINGS PHARM |
LIDOCAINE AND PRILOCAINE | LIDOCAINE; PRILOCAINE | 2.5%;2.5% | CREAM;TOPICAL | Prescription | No | AB | 213253 | RHODES PHARMS |