Details for New Drug Application (NDA): 201952
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The generic ingredient in TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN is acetaminophen; tramadol hydrochloride. There are sixty-six drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the acetaminophen; tramadol hydrochloride profile page.
Summary for 201952
Tradename: | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN |
Applicant: | Micro Labs Ltd India |
Ingredient: | acetaminophen; tramadol hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 201952
Mechanism of Action | Full Opioid Agonists |
Suppliers and Packaging for NDA: 201952
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | acetaminophen; tramadol hydrochloride | TABLET;ORAL | 201952 | ANDA | Micro Labs Limited | 42571-119 | 42571-119-01 | 100 TABLET, FILM COATED in 1 BOTTLE (42571-119-01) |
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | acetaminophen; tramadol hydrochloride | TABLET;ORAL | 201952 | ANDA | Micro Labs Limited | 42571-119 | 42571-119-05 | 500 TABLET, FILM COATED in 1 BOTTLE (42571-119-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 325MG;37.5MG | ||||
Approval Date: | Dec 14, 2012 | TE: | AB | RLD: | No |
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