Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208017
Company: SPECTRA MDCL DEVICES
Company: SPECTRA MDCL DEVICES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | AP | 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 |
|---|---|---|---|---|---|---|---|
| 04/18/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
LIDOCAINE HYDROCHLORIDE
INJECTABLE;INJECTION; 1%
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 215132 | AFAXYS |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 214336 | ASPIRO |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 214339 | ASPIRO |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 208474 | B BRAUN MEDICAL INC |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 207182 | EUGIA PHARMA |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 088586 | FRESENIUS KABI USA |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | Yes | AP | 083158 | HOSPIRA |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 088329 | HOSPIRA |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 212821 | HUONS |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | Yes | AP | 083173 | INTL MEDICATION |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 217692 | MANKIND PHARMA |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 217693 | MANKIND PHARMA |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 214267 | SINTETICA US |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 208017 | SPECTRA MDCL DEVICES |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 080407 | WEST-WARD PHARMS INT |
| LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 088586 | FRESENIUS KABI USA |
| LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 088299 | HOSPIRA |
| LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 203040 | EUGIA PHARMA |
| LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 203082 | EUGIA PHARMA |
| LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 084625 | HIKMA |
| LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 080408 | HOSPIRA |
| LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 040302 | HOSPIRA |
| XYLOCAINE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | Yes | AP | 006488 | FRESENIUS KABI USA |