Details for New Drug Application (NDA): 075077
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The generic ingredient in ACETAMINOPHEN is acetaminophen; caffeine; dihydrocodeine bitartrate. There are sixty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the acetaminophen; caffeine; dihydrocodeine bitartrate profile page.
Summary for 075077
Tradename: | ACETAMINOPHEN |
Applicant: | Perrigo |
Ingredient: | acetaminophen |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 075077
Suppliers and Packaging for NDA: 075077
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ACETAMINOPHEN | acetaminophen | TABLET, EXTENDED RELEASE;ORAL | 075077 | ANDA | L. Perrigo Company | 0113-0544 | 0113-0544-71 | 1 BOTTLE in 1 CARTON (0113-0544-71) / 50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE |
ACETAMINOPHEN | acetaminophen | TABLET, EXTENDED RELEASE;ORAL | 075077 | ANDA | L. Perrigo Company | 0113-0544 | 0113-0544-78 | 1 BOTTLE in 1 CARTON (0113-0544-78) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 650MG | ||||
Approval Date: | Feb 25, 2000 | TE: | RLD: | No |
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