Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 204494
Company: TELIGENT PHARMA INC
Company: TELIGENT PHARMA INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 4% | SOLUTION;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 |
|---|---|---|---|---|---|---|---|
| 03/12/2014 | ORIG-1 | Approval |
Label is not available on this site. |
LIDOCAINE HYDROCHLORIDE
SOLUTION;TOPICAL; 4%
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LARYNG-O-JET KIT | LIDOCAINE HYDROCHLORIDE | 4% | SOLUTION;TOPICAL | Prescription | No | AT | 086364 | INTL MEDICATION |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 4% | SOLUTION;TOPICAL | Prescription | No | AT | 204494 | TELIGENT PHARMA INC |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 4% | SOLUTION;TOPICAL | Prescription | No | AT | 088803 | WEST-WARD PHARMS INT |
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