Application 077500
- Type
- ANDA
- Sponsor
- SUN PHARM INDS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | LOPERAMIDE HYDROCHLORIDE; SIMETHICONE | TABLET;ORAL | 2MG;125MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 51660-069 | Loperamide HCl and Simethicone | Loperamide HCl and Simethicone | Ohm Laboratories Inc. | ANDA | Current |
| 51660-069 | Loperamide HCl and Simethicone | Loperamide HCl and Simethicone | Ohm Laboratories Inc. | ANDA | Current |
| 51660-069 | Loperamide HCl and Simethicone | Loperamide HCl and Simethicone | Ohm Laboratories Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 9054 | ORIG | 2006-09-15 |