Application 210453
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | GUAIFENESIN | GUAIFENESIN | TABLET, EXTENDED RELEASE;ORAL | 600MG | No | No |
| 002 | GUAIFENESIN | GUAIFENESIN | TABLET, EXTENDED RELEASE;ORAL | 1.2GM | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0363-0028 | Guaifenesin | Guaifenesin | WALGREEN CO. | ANDA | Current |
| 0363-0028 | Guaifenesin | Guaifenesin | WALGREEN CO. | ANDA | Current |
| 0363-0028 | Guaifenesin | Guaifenesin | WALGREEN CO. | ANDA | Current |
| 0363-0028 | Guaifenesin | Guaifenesin | WALGREEN CO. | ANDA | Current |
| 0363-0033 | Guaifenesin | Guaifenesin | WALGREEN CO. | ANDA | Current |
| 0363-0033 | Guaifenesin | Guaifenesin | WALGREEN CO. | ANDA | Current |
| 0363-0033 | Guaifenesin | Guaifenesin | WALGREEN CO. | ANDA | Current |
| 0363-0033 | Guaifenesin | Guaifenesin | WALGREEN CO. | ANDA | Current |
| 0363-0033 | Guaifenesin | Guaifenesin | WALGREEN CO. | ANDA | Current |
| 11822-4260 | Guaifenesin | Guaifenesin | RITE AID CORPORATION | ANDA | Current |
| 21130-179 | Guaifenesin | Guaifenesin | Better Living Brands LLC | ANDA | Current |
| 21130-399 | MUCUS RELIEF MAX | Guaifenesin | Better Living Brands, LLC | ANDA | Current |
| 21130-399 | MUCUS RELIEF MAX | Guaifenesin | Better Living Brands, LLC | ANDA | Current |
| 21130-399 | MUCUS RELIEF MAX | Guaifenesin | Better Living Brands, LLC | ANDA | Current |
| 21130-399 | MUCUS RELIEF MAX | Guaifenesin | Better Living Brands, LLC | ANDA | Current |
| 55319-902 | Guaifenesin | Guaifenesin | Family Dollar, Inc. | ANDA | Current |
| 55319-902 | Guaifenesin | Guaifenesin | Family Dollar, Inc. | ANDA | Current |
| 58602-810 | Guaifenesin | Guaifenesin | Aurohealth LLC | ANDA | Current |
| 58602-810 | Guaifenesin | Guaifenesin | Aurohealth LLC | ANDA | Current |
| 58602-810 | Guaifenesin | Guaifenesin | Aurohealth LLC | ANDA | Current |
| 58602-810 | Guaifenesin | Guaifenesin | Aurohealth LLC | ANDA | Current |
| 58602-810 | Guaifenesin | Guaifenesin | Aurohealth LLC | ANDA | Current |
| 58602-811 | Guaifenesin | Guaifenesin | Aurohealth LLC | ANDA | Current |
| 58602-811 | Guaifenesin | Guaifenesin | Aurohealth LLC | ANDA | Current |
| 58602-811 | Guaifenesin | Guaifenesin | Aurohealth LLC | ANDA | Current |
| 58602-811 | Guaifenesin | Guaifenesin | Aurohealth LLC | ANDA | Current |
| 58602-811 | Guaifenesin | Guaifenesin | Aurohealth LLC | ANDA | Current |
| 58602-811 | Guaifenesin | Guaifenesin | Aurohealth LLC | ANDA | Current |
| 58602-853 | Guaifenesin | Guaifenesin | Aurohealth LLC | ANDA | Current |
| 58602-853 | Guaifenesin | Guaifenesin | Aurohealth LLC | ANDA | Current |
| 58602-853 | Guaifenesin | Guaifenesin | Aurohealth LLC | ANDA | Current |
| 58602-853 | Guaifenesin | Guaifenesin | Aurohealth LLC | ANDA | Current |
| 58602-864 | Guaifenesin | Guaifenesin | Aurohealth LLC | ANDA | Current |
| 58602-864 | Guaifenesin | Guaifenesin | Aurohealth LLC | ANDA | Current |
| 58602-865 | Guaifenesin | Guaifenesin | Aurohealth LLC | ANDA | Current |
| 58602-865 | Guaifenesin | Guaifenesin | Aurohealth LLC | ANDA | Current |
| 68001-561 | Guaifenesin | Guaifenesin | BluePoint Laboratories | ANDA | Current |
| 71179-002 | Guaifenesin | Guaifenesin | VESPYR BRANDS, INC. | ANDA | Current |
| 79395-001 | Guaifenesin | Guaifenesin | Chalkboard Health | ANDA | Current |
| 79395-001 | Guaifenesin | Guaifenesin | Chalkboard Health | ANDA | Current |
| 79395-001 | Guaifenesin | Guaifenesin | Chalkboard Health | ANDA | Current |