Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202346
Company: MYLAN TECHNOLOGIES
Company: MYLAN TECHNOLOGIES
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LIDOCAINE | LIDOCAINE | 5% | PATCH;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 |
---|---|---|---|---|---|---|---|
08/07/2015 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/202346Orig1s000.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/02/2019 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
LIDOCAINE
PATCH;TOPICAL; 5%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LIDOCAINE | LIDOCAINE | 5% | PATCH;TOPICAL | Prescription | No | AB | 200675 | ACTAVIS LABS UT INC |
LIDOCAINE | LIDOCAINE | 5% | PATCH;TOPICAL | Prescription | No | AB | 206463 | AMNEAL |
LIDOCAINE | LIDOCAINE | 5% | PATCH;TOPICAL | Prescription | No | AB | 209190 | IBSA |
LIDOCAINE | LIDOCAINE | 5% | PATCH;TOPICAL | Prescription | No | AB | 202346 | MYLAN TECHNOLOGIES |
LIDOCAINE | LIDOCAINE | 5% | PATCH;TOPICAL | Prescription | No | AB | 205882 | NAL PHARM |
LIDODERM | LIDOCAINE | 5% | PATCH;TOPICAL | Prescription | Yes | AB | 020612 | TEIKOKU PHARMA USA |