Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020208
Company: BAUSCH
Company: BAUSCH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METROGEL-VAGINAL | METRONIDAZOLE | 0.75% | GEL;VAGINAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
08/17/1992 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/17/2002 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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07/28/1997 | SUPPL-7 | Labeling |
Label is not available on this site. |
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05/16/1997 | SUPPL-6 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
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02/07/1995 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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06/30/1995 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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01/06/1995 | SUPPL-3 | Labeling |
Label is not available on this site. |
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07/26/1993 | SUPPL-2 | Labeling |
Label is not available on this site. |
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03/17/1993 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
METROGEL-VAGINAL
GEL;VAGINAL; 0.75%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METROGEL-VAGINAL | METRONIDAZOLE | 0.75% | GEL;VAGINAL | Prescription | Yes | AB | 020208 | BAUSCH |
METRONIDAZOLE | METRONIDAZOLE | 0.75% | GEL;VAGINAL | Prescription | No | AB | 216323 | COSETTE |
METRONIDAZOLE | METRONIDAZOLE | 0.75% | GEL;VAGINAL | Prescription | No | AB | 215610 | ENCUBE |
METRONIDAZOLE | METRONIDAZOLE | 0.75% | GEL;VAGINAL | Prescription | No | AB | 215794 | GLENMARK PHARMS LTD |
METRONIDAZOLE | METRONIDAZOLE | 0.75% | GEL;VAGINAL | Prescription | No | AB | 211786 | PADAGIS ISRAEL |
METRONIDAZOLE | METRONIDAZOLE | 0.75% | GEL;VAGINAL | Prescription | No | AB | 213648 | SOLARIS PHARMA CORP |