Details for New Drug Application (NDA): 211438
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NDA 211438 describes LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE, which is a drug marketed by Perrigo, Aurobindo Pharma Ltd, Bionpharma, Granules, Guardian Drug, Hetero Labs Ltd V, Perrigo R And D, and Sun Pharm Inds Ltd, and is included in eight NDAs. It is available from thirty suppliers. Additional details are available on the LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE profile page.
The generic ingredient in LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE is loperamide hydrochloride; simethicone. There are eleven drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the loperamide hydrochloride; simethicone profile page.
The generic ingredient in LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE is loperamide hydrochloride; simethicone. There are eleven drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the loperamide hydrochloride; simethicone profile page.
Summary for 211438
| Tradename: | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE |
| Applicant: | Hetero Labs Ltd V |
| Ingredient: | loperamide hydrochloride; simethicone |
| Patents: | 0 |
Pharmacology for NDA: 211438
| Mechanism of Action | Opioid Agonists |
| Physiological Effect | Skin Barrier Activity |
Suppliers and Packaging for NDA: 211438
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | loperamide hydrochloride; simethicone | TABLET;ORAL | 211438 | ANDA | Camber Consumer Care Inc | 69230-325 | 69230-325-04 | 1 BLISTER PACK in 1 CARTON (69230-325-04) / 4 TABLET in 1 BLISTER PACK |
| LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | loperamide hydrochloride; simethicone | TABLET;ORAL | 211438 | ANDA | Camber Consumer Care Inc | 69230-325 | 69230-325-06 | 1 BLISTER PACK in 1 CARTON (69230-325-06) / 6 TABLET in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 2MG;125MG | ||||
| Approval Date: | Jun 17, 2021 | TE: | RLD: | No | |||||
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