Details for New Drug Application (NDA): 218122
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NDA 218122 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 218122
| Tradename: | LOPERAMIDE HYDROCHLORIDE |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | loperamide hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 218122
| Mechanism of Action | Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 218122
Suppliers and Packaging for NDA: 218122
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LOPERAMIDE HYDROCHLORIDE | loperamide hydrochloride | CAPSULE;ORAL | 218122 | ANDA | Major Pharmaceuticals | 0904-7472 | 0904-7472-61 | 100 BLISTER PACK in 1 CARTON (0904-7472-61) / 1 CAPSULE in 1 BLISTER PACK |
| LOPERAMIDE HYDROCHLORIDE | loperamide hydrochloride | CAPSULE;ORAL | 218122 | ANDA | A-S Medication Solutions | 50090-7398 | 50090-7398-0 | 15 CAPSULE in 1 BOTTLE (50090-7398-0) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 2MG | ||||
| Approval Date: | Sep 5, 2023 | TE: | AB | RLD: | No | ||||
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