Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020536
Company: MCNEIL CONS
Company: MCNEIL CONS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NICOTROL | NICOTINE | 15MG/16HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 07/03/1996 | ORIG-1 | Approval | Type 8 - Partial Rx to OTC Switch | 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 |
|---|---|---|---|---|---|
| 07/23/2002 | SUPPL-10 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20536slr010ltr.pdf |
| 11/26/1999 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/26/1999 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/01/2000 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/18/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/11/1997 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 04/01/1997 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |