Application 213420
- Type
- ANDA
- Sponsor
- GRANULES INDIA 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 |
|---|
| 0113-3650 | Good Sense Mucus ER | Guaifenesin | L. Perrigo Company | ANDA | Current |
| 0113-3650 | Good Sense Mucus ER | Guaifenesin | L. Perrigo Company | ANDA | Current |
| 0113-3650 | Good Sense Mucus ER | Guaifenesin | L. Perrigo Company | ANDA | Current |
| 0113-3650 | Good Sense Mucus ER | Guaifenesin | L. Perrigo Company | ANDA | Current |
| 41250-654 | mucus relief | guaifenesin | Meijer Distribution Inc | ANDA | Current |
| 41250-654 | mucus relief | guaifenesin | Meijer Distribution Inc | ANDA | Current |
| 46122-683 | good neighbor pharmacy mucus er | Guaifenesin | Amerisource Bergen | ANDA | Current |
| 46122-683 | good neighbor pharmacy mucus er | Guaifenesin | Amerisource Bergen | ANDA | Current |
| 53942-203 | Mucus Relief | Guaifenesin | Demoulas Super Markets, Inc | ANDA | Current |
| 53942-204 | Mucus Relief | Guaifenesin | Demoulas Super Markets, Inc | ANDA | Current |
| 55681-301 | MUCUS RELIEF | GUAIFENESIN | TWIN MED LLC | ANDA | Current |
| 55910-626 | dg health mucus er max | Guaifenesin | Dolgencorp Inc | ANDA | Current |
| 62207-569 | GUAIFENESIN | GUAIFENESIN | Granules India Ltd | ANDA | Current |
| 62207-569 | GUAIFENESIN | GUAIFENESIN | Granules India Ltd | ANDA | Current |
| 62207-569 | GUAIFENESIN | GUAIFENESIN | Granules India Ltd | ANDA | Current |
| 62207-569 | GUAIFENESIN | GUAIFENESIN | Granules India Ltd | ANDA | Current |
| 62207-570 | GUAIFENESIN | GUAIFENESIN | Granules India Ltd | ANDA | Current |
| 62207-570 | GUAIFENESIN | GUAIFENESIN | Granules India Ltd | ANDA | Current |
| 62207-570 | GUAIFENESIN | GUAIFENESIN | Granules India Ltd | ANDA | Current |
| 62207-697 | Guaifenesin Extended-Release Tablets, 600mg | Guaifenesin Extended-Release | Granules India Ltd | ANDA | Current |
| 62207-698 | Guaifensin Extended-Release Tablets, 1200 mg | Guaifensin Extended-Release | Granules India Ltd | ANDA | Current |
| 62207-839 | GUAIFENESIN | GUAIFENESIN | Granules India Ltd | ANDA | Current |
| 62207-839 | GUAIFENESIN | GUAIFENESIN | Granules India Ltd | ANDA | Current |
| 62207-839 | GUAIFENESIN | GUAIFENESIN | Granules India Ltd | ANDA | Current |
| 62207-840 | GUAIFENESIN | GUAIFENESIN | Granules India Ltd | ANDA | Current |
| 62207-840 | GUAIFENESIN | GUAIFENESIN | Granules India Ltd | ANDA | Current |
| 62207-840 | GUAIFENESIN | GUAIFENESIN | Granules India Ltd | ANDA | Current |
| 63868-148 | Maximum Strength Mucus Relief | Guaifenesin | CHAIN DRUG MARKETING ASSOCIATION INC | ANDA | Current |
| 63868-149 | 12 Hour Mucus Relief | Guaifenesin | CHAIN DRUG MARKETING ASSOCIATION INC | ANDA | Current |
| 68391-000 | berkley and jensen mucus relief | Guaifenesin | BJWC | ANDA | Current |
| 68391-000 | berkley and jensen mucus relief | Guaifenesin | BJWC | ANDA | Current |
| 69842-335 | Guaifenesin | Guaifenesin | CVS PHARMACY, INC | ANDA | Current |
| 69848-017 | Guaifenesin | Guaifenesin | GRANULES USA, INC. | ANDA | Current |
| 69848-018 | Guaifenesin | Guaifenesin | GRANULES USA, INC. | ANDA | Current |
| 70010-199 | GUAIFENESIN | GUAIFENESIN | GRANULES PHARMACEUTICALS INC. | ANDA | Current |
| 71141-168 | Mucus Relief | Guaifenesin | LIDL US LLC | ANDA | Current |
| 71309-460 | Safrel Mucus Relief | Guaifenesin | Safrel Pharmaceuticals, LLC. | ANDA | Current |
| 71309-461 | GUAIFENESIN | GUAIFENESIN | Safrel Pharmaceuticals, LLC. | ANDA | Current |
| 72288-650 | basic care mucus er max | Guaifenesin | Amazon.com Services LLC | ANDA | Current |
| 72288-650 | basic care mucus er max | Guaifenesin | Amazon.com Services LLC | ANDA | Current |
| 72559-013 | Curist Mucus Relief | Guaifenesin | Little Pharma, Inc. | ANDA | Current |
| 72559-013 | Curist Mucus Relief | Guaifenesin | Little Pharma, Inc. | ANDA | Current |
| 72559-013 | Curist Mucus Relief | Guaifenesin | Little Pharma, Inc. | ANDA | Current |
| 72559-017 | Curist Mucus Relief | Guaifenesin | Little Pharma, Inc. | ANDA | Current |
| 72559-017 | Curist Mucus Relief | Guaifenesin | Little Pharma, Inc. | ANDA | Current |
| 72559-017 | Curist Mucus Relief | Guaifenesin | Little Pharma, Inc. | ANDA | Current |
| 72559-017 | Curist Mucus Relief | Guaifenesin | Little Pharma, Inc. | ANDA | Current |
| 73581-401 | MUCUS RELIEF | GUAIFENESIN | YYBA CORP | ANDA | Current |
| 73581-402 | MUCUS RELIEF | GUAIFENESIN | YYBA CORP | ANDA | Current |
| 80267-002 | betr chest congestion relief | Guaifenesin | Live Betr LLC | ANDA | Current |
| 81179-007 | EXPECTORANT GUAIFENESIN EXTENDED-RELEASE | GUAIFENESIN | YET HEALTH GROUP LLC | ANDA | Current |
| 81179-007 | EXPECTORANT GUAIFENESIN EXTENDED-RELEASE | GUAIFENESIN | YET HEALTH GROUP LLC | ANDA | Current |
| 81179-007 | EXPECTORANT GUAIFENESIN EXTENDED-RELEASE | GUAIFENESIN | YET HEALTH GROUP LLC | ANDA | Current |
| 81179-007 | EXPECTORANT GUAIFENESIN EXTENDED-RELEASE | GUAIFENESIN | YET HEALTH GROUP LLC | ANDA | Current |
| 81522-203 | Mucus Relief | Guaifenesin | FSA STORE INC. | ANDA | Current |