Details for New Drug Application (NDA): 213070
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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 213070
Tradename: | LOPERAMIDE HYDROCHLORIDE |
Applicant: | Strides Pharma |
Ingredient: | loperamide hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 213070
Mechanism of Action | Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 213070
Suppliers and Packaging for NDA: 213070
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LOPERAMIDE HYDROCHLORIDE | loperamide hydrochloride | CAPSULE;ORAL | 213070 | ANDA | Dr. Reddy's Laboratories Inc. | 43598-770 | 43598-770-24 | 2 BLISTER PACK in 1 CARTON (43598-770-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK |
LOPERAMIDE HYDROCHLORIDE | loperamide hydrochloride | CAPSULE;ORAL | 213070 | ANDA | Strides Pharma Inc | 59556-959 | 59556-959-05 | 2 BLISTER PACK in 1 CARTON (59556-959-05) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (59556-959-03) |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | CAPSULE;ORAL | Strength | 2MG | ||||
Approval Date: | Aug 11, 2021 | TE: | RLD: | No |
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