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, Roxane, Rubicon, Strides Pharma, Teva, Zydus Lifesciences, Allied, Alpharma Us Pharms, Duramed Pharms Barr, Perrigo, Sciegen Pharms Inc, Watson Labs, Wockhardt Bio Ag, Perrigo R And D, 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-seven NDAs. It is available from one hundred and four 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 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 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 | A-S Medication Solutions | 50090-7398 | 50090-7398-0 | 15 CAPSULE in 1 BOTTLE (50090-7398-0) |
| LOPERAMIDE HYDROCHLORIDE | loperamide hydrochloride | CAPSULE;ORAL | 218122 | ANDA | A-S Medication Solutions | 50090-7398 | 50090-7398-3 | 12 CAPSULE in 1 BOTTLE (50090-7398-3) |
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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