Details for New Drug Application (NDA): 078002
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The generic ingredient in CAFFEINE CITRATE is caffeine citrate. There are eleven drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the caffeine citrate profile page.
Summary for 078002
Tradename: | CAFFEINE CITRATE |
Applicant: | Fresenius Kabi Usa |
Ingredient: | caffeine citrate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078002
Physiological Effect | Central Nervous System Stimulation |
Medical Subject Heading (MeSH) Categories for 078002
Suppliers and Packaging for NDA: 078002
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CAFFEINE CITRATE | caffeine citrate | SOLUTION;ORAL | 078002 | ANDA | Fresenius Kabi USA, LLC | 63323-406 | 63323-406-03 | 5 VIAL in 1 CARTON (63323-406-03) / 3 mL in 1 VIAL (63323-406-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | ||||
Approval Date: | Jan 31, 2008 | TE: | AA | RLD: | No |
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