Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084625
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | AP | No | No |
| LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE | LIDOCAINE HYDROCHLORIDE | 2% | 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 |
|---|---|---|---|---|---|---|---|
| 06/16/1975 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/20/1990 | SUPPL-55 | Labeling |
Label is not available on this site. |
||
| 04/21/2021 | SUPPL-46 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/29/2001 | SUPPL-43 | Labeling |
Label is not available on this site. |
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| 05/17/1999 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/24/1999 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/02/1998 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/04/1997 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/13/1996 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/13/1996 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/09/1994 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/07/1994 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/01/1992 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/07/1994 | SUPPL-31 | Labeling |
Label is not available on this site. |
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| 02/07/1994 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/24/1991 | SUPPL-29 | Labeling |
Label is not available on this site. |
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| 06/01/1992 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/20/1990 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 05/31/1989 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 04/26/1988 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/13/1985 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/22/1983 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/04/1982 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/27/1983 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/01/1982 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/15/1982 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
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 | 219535 | ANTHEA PHARMA |
| 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 |
| 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 | 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 | 208017 | SPECTRA MDCL DEVICES |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 220071 | VIWIT PHARM |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 080407 | WEST-WARD PHARMS INT |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 214267 | YILING |
| 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 | 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 |
INJECTABLE;INJECTION; 2%
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | No | AP | 219535 | ANTHEA PHARMA |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | No | AP | 214336 | ASPIRO |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | No | AP | 214339 | ASPIRO |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | No | AP | 207182 | EUGIA PHARMA |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | No | AP | 088586 | FRESENIUS KABI USA |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | No | AP | 040078 | HOSPIRA |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | No | AP | 088294 | HOSPIRA |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | No | AP | 212821 | HUONS |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | No | AP | 083173 | INTL MEDICATION |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | No | AP | 217692 | MANKIND PHARMA |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | No | AP | 217693 | MANKIND PHARMA |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | No | AP | 220071 | VIWIT PHARM |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | No | AP | 080407 | WEST-WARD PHARMS INT |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | No | AP | 214267 | YILING |
| LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | No | AP | 088327 | HOSPIRA |
| LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | No | AP | 203082 | EUGIA PHARMA |
| LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | No | AP | 017584 | FRESENIUS KABI USA |
| LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | No | AP | 084625 | HIKMA |
| LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | No | AP | 040302 | HOSPIRA |
| XYLOCAINE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | Yes | AP | 006488 | FRESENIUS KABI USA |