Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086283
Company: INTL MEDICATION
Company: INTL MEDICATION
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | JELLY;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 |
---|---|---|---|---|---|---|---|
08/07/1979 | 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 |
---|---|---|---|---|---|
09/19/1995 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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06/17/1994 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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08/25/1993 | SUPPL-14 | Labeling |
Label is not available on this site. |
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12/17/1992 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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02/08/1993 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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07/10/1987 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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03/05/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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05/16/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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05/16/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
LIDOCAINE HYDROCHLORIDE
JELLY;TOPICAL; 2%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GLYDO | LIDOCAINE HYDROCHLORIDE | 2% | JELLY;TOPICAL | Prescription | No | AT | 201094 | SAGENT PHARMS INC |
LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | JELLY;TOPICAL | Prescription | No | AT | 086283 | INTL MEDICATION |
LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | JELLY;TOPICAL | Prescription | No | AT | 040433 | SENTISS |