Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020574
Company: BAYER HEALTHCARE LLC
Company: BAYER HEALTHCARE LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GYNE-LOTRIMIN 3 | CLOTRIMAZOLE | 2% | CREAM;VAGINAL | Discontinued | None | Yes | 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 |
---|---|---|---|---|---|---|---|
11/24/1998 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20574lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20574ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-574_GyneLotrimin.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/12/2010 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020574s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020574s006ltr.pdf | |
01/16/2002 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/01/2000 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/27/1999 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/12/2010 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020574s006lbl.pdf | |
11/24/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20574lbl.pdf |