Application 021416
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | RYTHMOL SR | PROPAFENONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 225MG | Yes | No |
| 002 | RYTHMOL SR | PROPAFENONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 325MG | Yes | No |
| 003 | RYTHMOL SR | PROPAFENONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 425MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0173-0823 | RYTHMOL | propafenone hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0823 | RYTHMOL | propafenone hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0823 | RYTHMOL | propafenone hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0823 | RYTHMOL | propafenone hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0823 | RYTHMOL | propafenone hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0824 | RYTHMOL | propafenone hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0824 | RYTHMOL | propafenone hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0824 | RYTHMOL | propafenone hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0824 | RYTHMOL | propafenone hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0824 | RYTHMOL | propafenone hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0826 | RYTHMOL | propafenone hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0826 | RYTHMOL | propafenone hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0826 | RYTHMOL | propafenone hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0826 | RYTHMOL | propafenone hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0826 | RYTHMOL | propafenone hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 66993-114 | Propafenone Hydrochloride | propafenone hydrochloride | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-114 | Propafenone Hydrochloride | propafenone hydrochloride | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-115 | Propafenone Hydrochloride | propafenone hydrochloride | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-115 | Propafenone Hydrochloride | propafenone hydrochloride | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-116 | Propafenone Hydrochloride | propafenone hydrochloride | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-116 | Propafenone Hydrochloride | propafenone hydrochloride | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 56329 | SUPPL | 2018-11-07 |
| 56253 | SUPPL | 2018-11-02 |
| 15415 | SUPPL | 2014-06-23 |
| 27724 | SUPPL | 2011-04-19 |
| 15414 | SUPPL | 2011-04-15 |
| 27723 | SUPPL | 2010-11-03 |
| 36866 | SUPPL | 2010-10-29 |
| 27722 | SUPPL | 2004-09-15 |
| 42144 | ORIG | 2004-02-11 |
| 36865 | ORIG | 2003-09-25 |
| 5307 | ORIG | 2003-09-25 |