Application 214541
- Type
- ANDA
- Sponsor
- GUARDIAN DRUG
Application Products#
| 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 | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 53041-263 | Loperamide Hydrochloride, Simethicone | Loperamide Hydrochloride, Simethicone | Guardian Drug Company | ANDA | Current |
| 76864-100 | Intestinomicina | Loperamide HCI, Simethicone | Procaps S.A. de C.V. | ANDA | Current |
| 79903-116 | Anti-Diarrheal/Anti-Gas Multi-Symptom Relief | Loperamide Hydrochloride 2mg, Simethicone 125mg | Wal-Mart Stores, Inc. | ANDA | Current |