Drugs@FDA: FDA-Approved Drugs
Company: WOCKHARDT BIO AG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | SOLUTION;ORAL | 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 |
---|---|---|---|---|---|---|---|
11/18/1982 | 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 |
---|---|---|---|---|---|
11/02/2018 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
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12/01/2014 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
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12/18/2003 | SUPPL-22 | Labeling |
Label is not available on this site. |
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01/10/2003 | SUPPL-21 | Labeling |
Label is not available on this site. |
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12/02/1996 | SUPPL-17 | Labeling |
Label is not available on this site. |
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12/02/1996 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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12/02/1996 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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12/02/1996 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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12/02/1996 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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04/12/1994 | SUPPL-12 | Labeling |
Label is not available on this site. |
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10/10/1991 | SUPPL-11 | Labeling |
Label is not available on this site. |
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04/04/1990 | SUPPL-10 | Labeling |
Label is not available on this site. |
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09/08/1993 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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05/14/1987 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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04/30/1986 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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10/18/1984 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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10/18/1984 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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10/03/1983 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
LIDOCAINE HYDROCHLORIDE
SOLUTION;ORAL; 2%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | SOLUTION;ORAL | Prescription | No | AT | 216780 | RUBICON |
LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | SOLUTION;ORAL | Prescription | No | AT | 087872 | WOCKHARDT BIO AG |
LIDOCAINE HYDROCHLORIDE VISCOUS | LIDOCAINE HYDROCHLORIDE | 2% | SOLUTION;ORAL | Prescription | No | AT | 040708 | CHARTWELL MOLECULAR |
LIDOCAINE HYDROCHLORIDE VISCOUS | LIDOCAINE HYDROCHLORIDE | 2% | SOLUTION;ORAL | Prescription | No | AT | 218138 | PAI HOLDINGS PHARM |
LIDOCAINE VISCOUS | LIDOCAINE HYDROCHLORIDE | 2% | SOLUTION;ORAL | Prescription | No | AT | 088802 | HIKMA |