Application 020692
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SEREVENT | SALMETEROL XINAFOATE | POWDER;INHALATION | EQ 0.05MG BASE/INH | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0173-0520 | SEREVENT | salmeterol xinafoate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0520 | SEREVENT | salmeterol xinafoate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0520 | SEREVENT | salmeterol xinafoate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0520 | SEREVENT | salmeterol xinafoate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0520 | SEREVENT | salmeterol xinafoate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0521 | SEREVENT | salmeterol xinafoate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0521 | SEREVENT | salmeterol xinafoate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0521 | SEREVENT | salmeterol xinafoate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0521 | SEREVENT | salmeterol xinafoate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0521 | SEREVENT | salmeterol xinafoate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0521 | SEREVENT | salmeterol xinafoate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0521 | SEREVENT | salmeterol xinafoate | GlaxoSmithKline LLC | NDA | Current |
| 68258-8961 | SEREVENT | salmeterol xinafoate | Dispensing Solutions, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 59412 | SUPPL | 2019-07-23 |
| 59402 | SUPPL | 2019-07-23 |
| 59401 | SUPPL | 2019-07-23 |
| 57074 | SUPPL | 2018-12-31 |
| 57011 | SUPPL | 2018-12-26 |
| 57010 | SUPPL | 2018-12-26 |
| 45585 | SUPPL | 2016-10-06 |
| 45475 | SUPPL | 2016-10-05 |
| 35149 | SUPPL | 2014-04-16 |
| 25527 | SUPPL | 2014-04-16 |
| 25526 | SUPPL | 2012-08-13 |
| 3094 | SUPPL | 2011-07-05 |
| 43666 | SUPPL | 2011-05-16 |
| 35148 | SUPPL | 2011-05-16 |
| 25525 | SUPPL | 2011-05-12 |
| 13216 | SUPPL | 2011-01-04 |
| 3092 | SUPPL | 2011-01-04 |
| 25524 | SUPPL | 2010-11-22 |
| 3093 | SUPPL | 2010-06-29 |
| 35147 | SUPPL | 2010-06-28 |
| 20828 | SUPPL | 2008-08-01 |
| 13215 | SUPPL | 2008-03-24 |
| 25523 | SUPPL | 2008-03-21 |
| 3090 | SUPPL | 2007-03-01 |
| 35146 | SUPPL | 2007-02-26 |
| 3091 | SUPPL | 2006-03-23 |
| 13214 | SUPPL | 2006-03-03 |
| 41558 | ORIG | 2005-12-06 |
| 23591 | ORIG | 2005-11-30 |
| 35145 | SUPPL | 2004-10-04 |
| 25522 | SUPPL | 2004-10-04 |
| 25521 | SUPPL | 2003-08-15 |
| 13213 | SUPPL | 2003-08-15 |
| 13212 | SUPPL | 2002-03-22 |
| 3089 | SUPPL | 2002-03-22 |
| 41559 | SUPPL | 1998-09-25 |
| 35144 | SUPPL | 1998-09-25 |
| 25520 | SUPPL | 1998-09-25 |
| 20827 | SUPPL | 1998-09-25 |
| 13211 | SUPPL | 1998-09-25 |
| 3088 | SUPPL | 1998-09-25 |