Details for New Drug Application (NDA): 078569
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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 078569
Tradename: | ACETAMINOPHEN |
Applicant: | Sun Pharm Inds Ltd |
Ingredient: | acetaminophen |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 078569
Suppliers and Packaging for NDA: 078569
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ACETAMINOPHEN | acetaminophen | TABLET, EXTENDED RELEASE;ORAL | 078569 | ANDA | Walgreen Company | 0363-0340 | 0363-0340-08 | 80 TABLET, EXTENDED RELEASE in 1 BOTTLE (0363-0340-08) |
ACETAMINOPHEN | acetaminophen | TABLET, EXTENDED RELEASE;ORAL | 078569 | ANDA | CVS Pharmacy | 69842-930 | 69842-930-80 | 80 TABLET, EXTENDED RELEASE in 1 BOTTLE (69842-930-80) |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 650MG | ||||
Approval Date: | Dec 14, 2011 | TE: | RLD: | No |
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