Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076320
Company: ENCUBE
Company: ENCUBE
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 | 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 |
---|---|---|---|---|---|---|---|
08/27/2003 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/28/2012 | SUPPL-18 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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10/23/2009 | SUPPL-12 | Labeling |
Label is not available on this site. |
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07/10/2007 | SUPPL-10 | Labeling |
Label is not available on this site. |
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10/22/2007 | SUPPL-8 | Labeling |
Label is not available on this site. |
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08/11/2004 | SUPPL-2 | Labeling |
Label is not available on this site. |
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 |