Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206297
Company: AMNEAL PHARMS
Company: AMNEAL PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LIDOCAINE | LIDOCAINE | 5% | OINTMENT;TOPICAL | Prescription | AT | 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 | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206297Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/02/2018 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
04/09/2018 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
06/20/2017 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
06/20/2017 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
06/20/2017 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
LIDOCAINE
OINTMENT;TOPICAL; 5%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LIDOCAINE | LIDOCAINE | 5% | OINTMENT;TOPICAL | Prescription | No | AT | 211469 | ALEMBIC |
LIDOCAINE | LIDOCAINE | 5% | OINTMENT;TOPICAL | Prescription | No | AT | 207810 | ALKEM LABS LTD |
LIDOCAINE | LIDOCAINE | 5% | OINTMENT;TOPICAL | Prescription | No | AT | 206297 | AMNEAL PHARMS |
LIDOCAINE | LIDOCAINE | 5% | OINTMENT;TOPICAL | Prescription | No | AT | 208660 | DR REDDYS |
LIDOCAINE | LIDOCAINE | 5% | OINTMENT;TOPICAL | Prescription | Yes | AT | 080198 | FOUGERA PHARMS INC |
LIDOCAINE | LIDOCAINE | 5% | OINTMENT;TOPICAL | Prescription | No | AT | 206498 | GLENMARK PHARMS LTD |
LIDOCAINE | LIDOCAINE | 5% | OINTMENT;TOPICAL | Prescription | No | AT | 211697 | MACLEODS PHARMS LTD |
LIDOCAINE | LIDOCAINE | 5% | OINTMENT;TOPICAL | Prescription | No | AT | 212695 | QUAGEN |
LIDOCAINE | LIDOCAINE | 5% | OINTMENT;TOPICAL | Prescription | No | AT | 040911 | SEPTODONT INC |
LIDOCAINE | LIDOCAINE | 5% | OINTMENT;TOPICAL | Prescription | No | AT | 210958 | STRIDES PHARMA |
LIDOCAINE | LIDOCAINE | 5% | OINTMENT;TOPICAL | Prescription | No | AT | 086724 | TARO |