Details for New Drug Application (NDA): 202076
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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 202076
Tradename: | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN |
Applicant: | Alkem Labs Ltd |
Ingredient: | acetaminophen; tramadol hydrochloride |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 325MG;37.5MG | ||||
Approval Date: | Mar 30, 2012 | TE: | AB | RLD: | No |
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