Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213923
Company: ALEMBIC
Company: ALEMBIC
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 |
---|---|---|---|---|---|---|---|
04/08/2022 | ORIG-1 | Approval | 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 |
---|---|---|---|---|---|
08/10/2022 | SUPPL-1 | Labeling-Package Insert |
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 |