Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020889
Company: SCHERING PLOUGH
Company: SCHERING PLOUGH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LOTRIMIN AF | CLOTRIMAZOLE | 1% | Lotion; Topical | Over-the-counter | 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 |
---|---|---|---|---|---|---|---|
10/27/1989 | ORIG-1 | Approval | UNKNOWN |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/16/2002 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/07/2001 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/04/1999 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/01/2001 | SUPPL-2 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20889s2lbl.pdf | |
05/19/1998 | 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 |
---|---|---|---|---|---|
08/01/2001 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20889s2lbl.pdf |
LOTRIMIN AF
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
Lotion; Topical; 1%
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
LOTRIMIN AF | CLOTRIMAZOLE | 1% | Lotion; Topical | Over-the-counter | Yes | 020889 | SCHERING PLOUGH |