Details for New Drug Application (NDA): 020793
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NDA 020793 describes CAFCIT, which is a drug marketed by Hikma and is included in one NDA. It is available from one supplier. Additional details are available on the CAFCIT profile page.
The generic ingredient in CAFCIT 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 CAFCIT 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 020793
| Tradename: | CAFCIT |
| Applicant: | Hikma |
| Ingredient: | caffeine citrate |
| Patents: | 0 |
Pharmacology for NDA: 020793
| Physiological Effect | Central Nervous System Stimulation |
Medical Subject Heading (MeSH) Categories for 020793
Suppliers and Packaging for NDA: 020793
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CAFCIT | caffeine citrate | SOLUTION;INTRAVENOUS | 020793 | NDA | Hikma Pharmaceuticals USA Inc. | 0641-6164 | 0641-6164-10 | 10 VIAL in 1 BOX (0641-6164-10) / 3 mL in 1 VIAL (0641-6164-01) |
| CAFCIT | caffeine citrate | SOLUTION;INTRAVENOUS | 020793 | NDA | Hikma Pharmaceuticals USA Inc. | 0641-6267 | 0641-6267-10 | 10 VIAL in 1 BOX (0641-6267-10) / 3 mL in 1 VIAL (0641-6267-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | ||||
| Approval Date: | Sep 21, 1999 | TE: | AP | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;ORAL | Strength | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Apr 12, 2000 | TE: | RLD: | Yes | |||||
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