Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204494
Company: PAI HOLDINGS PHARM
Company: PAI HOLDINGS PHARM
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 | 088803 | HIKMA |
LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 4% | SOLUTION;TOPICAL | Prescription | No | AT | 040710 | LANNETT CO INC |
LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 4% | SOLUTION;TOPICAL | Prescription | No | AT | 216250 | NOVITIUM PHARMA |
LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 4% | SOLUTION;TOPICAL | Prescription | No | AT | 204494 | PAI HOLDINGS PHARM |
LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 4% | SOLUTION;TOPICAL | Prescription | No | AT | 218182 | TARO |
LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 4% | SOLUTION;TOPICAL | Prescription | No | AT | 218411 | THE J MOLNER |
LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 4% | SOLUTION;TOPICAL | Prescription | No | AT | 087881 | WOCKHARDT BIO AG |