Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 205318
Company: TELIGENT PHARMA INC
Company: TELIGENT PHARMA INC
| 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 |
|---|---|---|---|---|---|---|---|
| 02/01/2016 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205318Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/02/2018 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/17/2017 | SUPPL-1 | Labeling-Package Insert, Labeling-Container/Carton Labels |
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 | 211019 | ACP NIMBLE |
| LIDOCAINE | LIDOCAINE | 5% | OINTMENT;TOPICAL | Prescription | No | AT | 211469 | ALEOR DERMACEUTICALS |
| 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 | 080198 | FOUGERA PHARMS INC |
| LIDOCAINE | LIDOCAINE | 5% | OINTMENT;TOPICAL | Prescription | No | AT | 206498 | GLENMARK PHARMS LTD |
| LIDOCAINE | LIDOCAINE | 5% | OINTMENT;TOPICAL | Prescription | No | AT | 208604 | RICONPHARMA LLC |
| 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 |
| LIDOCAINE | LIDOCAINE | 5% | OINTMENT;TOPICAL | Prescription | No | AT | 205318 | TELIGENT PHARMA INC |
| LIDOCAINE | LIDOCAINE | 5% | OINTMENT;TOPICAL | Prescription | No | AT | 210256 | TEVA PHARMS USA |
| LIDOCAINE | LIDOCAINE | 5% | OINTMENT;TOPICAL | Prescription | No | AT | 208822 | VITRUVIAS THERAP |
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