Details for New Drug Application (NDA): 077997
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NDA 077997 describes CAFFEINE CITRATE, which is a drug marketed by Am Regent, Eugia Pharma, Exela Pharma Science, Fresenius Kabi Usa, Micro Labs, Sagent Pharms, Sun Pharm, and Exela Pharma, and is included in thirteen NDAs. It is available from eight suppliers. Additional details are available on the CAFFEINE CITRATE profile page.
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.
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 077997
| Tradename: | CAFFEINE CITRATE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | caffeine citrate |
| Patents: | 0 |
Pharmacology for NDA: 077997
| Physiological Effect | Central Nervous System Stimulation |
Medical Subject Heading (MeSH) Categories for 077997
Suppliers and Packaging for NDA: 077997
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CAFFEINE CITRATE | caffeine citrate | SOLUTION;INTRAVENOUS | 077997 | ANDA | Fresenius Kabi USA, LLC | 63323-407 | 63323-407-03 | 1 VIAL in 1 BOX (63323-407-03) / 3 mL in 1 VIAL |
| CAFFEINE CITRATE | caffeine citrate | SOLUTION;INTRAVENOUS | 077997 | ANDA | Fresenius Kabi USA, LLC | 63323-407 | 63323-407-04 | 1 VIAL in 1 BOX (63323-407-04) / 3 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | ||||
| Approval Date: | Jul 20, 2007 | TE: | AP | RLD: | No | ||||
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