Details for New Drug Application (NDA): 216876
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NDA 216876 describes LOPERAMIDE HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma Ltd, Bionpharma, Chartwell Rx, Edenbridge Pharms, Jubilant Cadista, Mylan, Onesource Specialty, Roxane, Rubicon Research, Teva, Zydus Lifesciences, Allied, Alpharma Us Pharms, Duramed Pharms Barr, Pai Holdings, Perrigo, Perrigo R And D, Watson Labs, Wockhardt Bio Ag, Able, Aurobindo Pharma, Contract Pharmacal, L Perrigo Co, LNK, Ohm Labs, Granules, Guardian Drug, Hetero Labs Ltd V, and Sun Pharm Inds Ltd, and is included in thirty-eight NDAs. It is available from ninety-eight suppliers. Additional details are available on the LOPERAMIDE HYDROCHLORIDE profile page.
The generic ingredient in LOPERAMIDE HYDROCHLORIDE is loperamide hydrochloride; simethicone. There are eleven drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the loperamide hydrochloride; simethicone profile page.
The generic ingredient in LOPERAMIDE HYDROCHLORIDE is loperamide hydrochloride; simethicone. There are eleven drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the loperamide hydrochloride; simethicone profile page.
Summary for 216876
| Tradename: | LOPERAMIDE HYDROCHLORIDE |
| Applicant: | Rubicon Research |
| Ingredient: | loperamide hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 216876
| Mechanism of Action | Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 216876
Suppliers and Packaging for NDA: 216876
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LOPERAMIDE HYDROCHLORIDE | loperamide hydrochloride | CAPSULE;ORAL | 216876 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8497 | 0615-8497-39 | 30 CAPSULE in 1 BLISTER PACK (0615-8497-39) |
| LOPERAMIDE HYDROCHLORIDE | loperamide hydrochloride | CAPSULE;ORAL | 216876 | ANDA | RedPharm Drug | 67296-2113 | 67296-2113-5 | 15 CAPSULE in 1 BOTTLE (67296-2113-5) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 2MG | ||||
| Approval Date: | Jan 26, 2023 | TE: | AB | RLD: | No | ||||
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