Details for New Drug Application (NDA): 209837
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NDA 209837 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 twenty-nine 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 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 suppliers are listed for this compound. Additional details are available on the loperamide hydrochloride; simethicone profile page.
Summary for 209837
| Tradename: | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE |
| Applicant: | Perrigo R And D |
| Ingredient: | loperamide hydrochloride; simethicone |
| Patents: | 0 |
Pharmacology for NDA: 209837
| Mechanism of Action | Opioid Agonists |
| Physiological Effect | Skin Barrier Activity |
Suppliers and Packaging for NDA: 209837
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | loperamide hydrochloride; simethicone | TABLET;ORAL | 209837 | ANDA | L. Perrigo Company | 0113-0087 | 0113-0087-53 | 12 BLISTER PACK in 1 CARTON (0113-0087-53) / 1 TABLET in 1 BLISTER PACK |
| LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | loperamide hydrochloride; simethicone | TABLET;ORAL | 209837 | ANDA | L. Perrigo Company | 0113-0087 | 0113-0087-62 | 24 BLISTER PACK in 1 CARTON (0113-0087-62) / 1 TABLET in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 2MG;125MG | ||||
| Approval Date: | Sep 5, 2018 | TE: | RLD: | No | |||||
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