Caffeine Oral Solution
- Brand(s)
- Cafcit
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Bedford Laboratories (2014-05-27)
- Oldest Current Product
- 2006-09-21
- License(s)
- NDA, ANDA
- RxNORM
- ORAL SOLUTION\CAFFEINE
- FDAOB
- INTRAVENOUS\SOLUTION\CAFFEINE CITRATE
ORAL\SOLUTION\CAFFEINE CITRATE - SPL Active
- ORAL\SOLUTION\CAFFEINE CITRATE
- SPL Moiety
- ORAL\SOLUTION\CAFFEINE
product(s) by strength(s)
caffeine citrate 20 mg/ml oral solution
original product(s)(s)
| # | id | brand | category | labeler | first marketed | last marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 553900358 | Cafcit | NDA | Bedford Laboratories | 2008-11-04 | 2016-05-29 | CAFFEINE CITRATE | ORAL | SOLUTION | NDA020793 | fbcd234e-57e1-4da2-a96c-e3f7b7cf6ec0 |
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 250210602 | ANDA | Sagent Pharmaceuticals | 2012-09-15 | CAFFEINE CITRATE | ORAL | SOLUTION | ANDA091102 | 5f38c395-0093-4afd-89ec-f96e5dc0934a |
| 2 | 473350290 | ANDA | Sun Pharma Global Fze | 2009-10-01, 2014-06-02 | CAFFEINE CITRATE | ORAL | SOLUTION | ANDA090357 | cc632825-e0a4-4524-8d7d-ce926efab3d6, d06d3810-9923-4199-be5e-ee5ee086b0a4 |
| 3 | 517540501 | ANDA | Exela Pharma Sciences, Llc | 2006-09-21 | CAFFEINE CITRATE | ORAL | SOLUTION | ANDA077304 | 5d05ebf4-fd27-3bd1-5634-b41e33abc41f |
| 4 | 517540503 | ANDA | Exela Pharma Sciences, Llc | 2006-09-21 | CAFFEINE CITRATE | ORAL | SOLUTION | ANDA077304 | bd6ac18d-c65c-42bc-a3ca-7a428c13aae7 |
| 5 | 627560290 | ANDA | Sun Pharmaceutical Industries Limited | 2009-10-01 | CAFFEINE CITRATE | ORAL | SOLUTION | ANDA090357 | dfa7e0a9-eac0-4741-9b85-69c122f13e33 |
| 6 | 633230406 | ANDA | App Pharmaceuticals, Llc | 2009-11-19 | CAFFEINE CITRATE | ORAL | SOLUTION | ANDA078002 | b4fb7c77-1e82-48b7-83c5-dd04ec7c5c4e |
relabeler product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 521250734 | ANDA | Remedyrepack Inc. | 2013-10-04, 2013-10-31 | CAFFEINE CITRATE | ORAL | SOLUTION | 473350290 | ANDA090357 | 0f52c2f7-15f0-4270-924d-fc2992a1e36b, 3ff5003e-7202-4606-8685-7238a23fec1e |
application(s)
| # | id | title | applicant | approved | approved drug | in other drug docs |
|---|---|---|---|---|---|---|
| 1 | ANDA077233 | CAFFEINE CITRATE | EXELA PHARMA SCIENCES | 2006-09-21 | ANDA077233_001 | Caffeine Injectable Solution |
| 2 | ANDA077304 | CAFFEINE CITRATE | EXELA PHARMA SCIENCES LLC | 2006-09-21 | ANDA077304_001 | Caffeine Injectable Solution |
| 3 | ANDA077906 | CAFFEINE CITRATE | LUITPOLD PHARMACEUTICALS INC | 2007-05-15 | ANDA077906_001 | Caffeine Injectable Solution |
| 4 | ANDA077997 | CAFFEINE CITRATE | FRESENIUS KABI USA LLC | 2007-07-20 | ANDA077997_001 | Caffeine Injectable Solution |
| 5 | ANDA078002 | CAFFEINE CITRATE | FRESENIUS KABI USA LLC | 2008-01-31 | ANDA078002_001 | Caffeine Injectable Solution |
| 6 | ANDA090064 | CAFFEINE CITRATE | LUITPOLD PHARMACEUTICALS INC | 2009-11-20 | ANDA090064_001 | Caffeine Injectable Solution |
| 7 | ANDA090077 | CAFFEINE CITRATE | SUN PHARMA GLOBAL FZE | 2009-09-30 | ANDA090077_001 | Caffeine Injectable Solution |
| 8 | ANDA090357 | CAFFEINE CITRATE | SUN PHARMA GLOBAL FZE | 2009-09-30 | ANDA090357_001 | Caffeine Injectable Solution |
| 9 | ANDA090827 | CAFFEINE CITRATE | SAGENT PHARMACEUTICALS INC | 2012-08-29 | ANDA090827_001 | Caffeine Injectable Solution |
| 10 | ANDA091102 | CAFFEINE CITRATE | SAGENT PHARMACEUTICALS INC | 2012-08-29 | ANDA091102_001 | Caffeine Injectable Solution |
| 11 | ANDA205013 | CAFFEINE CITRATE | AUROBINDO PHARMA LTD | 2015-09-22 | ANDA205013_001 | Caffeine Injectable Solution |
| 12 | NDA020793 | CAFCIT | EUROHEALTH INTERNATIONAL SARL | 1999-09-21 | NDA020793_001, NDA020793_002 | Caffeine Injectable Solution |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|---|
| 1 | ANDA077233_001 | RX | CAFFEINE CITRATE (EQ 30MG BASE/3ML) | INTRAVENOUS | SOLUTION | False | AP | 2006-09-21 | CAFFEINE CITRATE |
| 2 | ANDA077304_001 | RX | CAFFEINE CITRATE (EQ 30MG BASE/3ML) | ORAL | SOLUTION | False | AA | 2006-09-21 | CAFFEINE CITRATE |
| 3 | ANDA077906_001 | RX | CAFFEINE CITRATE (EQ 30MG BASE/3ML) | INTRAVENOUS | SOLUTION | False | AP | 2007-05-15 | CAFFEINE CITRATE |
| 4 | ANDA077997_001 | RX | CAFFEINE CITRATE (EQ 30MG BASE/3ML) | INTRAVENOUS | SOLUTION | False | AP | 2007-07-20 | CAFFEINE CITRATE |
| 5 | ANDA078002_001 | RX | CAFFEINE CITRATE (EQ 30MG BASE/3ML) | ORAL | SOLUTION | False | AA | 2008-01-31 | CAFFEINE CITRATE |
| 6 | ANDA090064_001 | RX | CAFFEINE CITRATE (EQ 30MG BASE/3ML) | ORAL | SOLUTION | False | AA | 2009-11-20 | CAFFEINE CITRATE |
| 7 | ANDA090077_001 | RX | CAFFEINE CITRATE (EQ 30MG BASE/3ML) | INTRAVENOUS | SOLUTION | False | AP | 2009-09-30 | CAFFEINE CITRATE |
| 8 | ANDA090357_001 | RX | CAFFEINE CITRATE (EQ 30MG BASE/3ML) | ORAL | SOLUTION | False | AA | 2009-09-30 | CAFFEINE CITRATE |
| 9 | ANDA090827_001 | RX | CAFFEINE CITRATE (EQ 30MG BASE/3ML) | INTRAVENOUS | SOLUTION | False | AP | 2012-08-29 | CAFFEINE CITRATE |
| 10 | ANDA091102_001 | RX | CAFFEINE CITRATE (EQ 30MG BASE/3ML) | ORAL | SOLUTION | False | AA | 2012-08-29 | CAFFEINE CITRATE |
| 11 | ANDA205013_001 | RX | CAFFEINE CITRATE (EQ 30MG BASE/3ML) | INTRAVENOUS | SOLUTION | False | AP | 2015-09-22 | CAFFEINE CITRATE |
| 12 | NDA020793_001 | RX | CAFFEINE CITRATE (EQ 30MG BASE/3ML) | INTRAVENOUS | SOLUTION | True | AP | 1999-09-21 | CAFCIT |
| 13 | NDA020793_002 | RX | CAFFEINE CITRATE (EQ 30MG BASE/3ML) | ORAL | SOLUTION | True | AA | 2000-04-12 | CAFCIT |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) | in other drug docs |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 0f52c2f7-15f0-4270-924d-fc2992a1e36b (view SPL) | Caffeine Citrate Injection, USP Caffeine Citrate Oral Solution, USP | prescription | Human Prescription | Remedyrepack Inc. | 2013-10-31 | 1 | 521250734 | ||
| 2 | 3ff5003e-7202-4606-8685-7238a23fec1e (view SPL) | Caffeine Citrate Injection, USP Caffeine Citrate Oral Solution, USP | prescription | Human Prescription | Remedyrepack Inc. | 2013-10-04 | 1 | 521250734 | ||
| 3 | 5d05ebf4-fd27-3bd1-5634-b41e33abc41f (view SPL) | prescription | Human Prescription | Exela Pharma Sciences, Llc | MANUFACTURE | 2015-03-26 | 2 | 517540501 | ||
| 4 | 5f38c395-0093-4afd-89ec-f96e5dc0934a (view SPL) | Caffeine Citrate Injection, USPCaffeine Citrate Oral Solution, USP | prescription | Human Prescription | Sagent Pharmaceuticals | 2014-09-15 | 6 | 250210602, 250210601 | Caffeine Injectable Solution | |
| 5 | b4fb7c77-1e82-48b7-83c5-dd04ec7c5c4e (view SPL) | Caffeine Citrate Oral Solution, USP | prescription | Human Prescription | App Pharmaceuticals, Llc | MANUFACTURE | 2009-12-15 | 3 | 633230406 | |
| 6 | bd6ac18d-c65c-42bc-a3ca-7a428c13aae7 (view SPL) | prescription | Human Prescription | Exela Pharma Sciences, Llc | manufacture | 2015-09-09 | 1 | 517540503 | ||
| 7 | cc632825-e0a4-4524-8d7d-ce926efab3d6 (view SPL) | Caffeine Citrate Injection, USP Caffeine Citrate Oral Solution, USP | prescription | Human Prescription | Sun Pharma Global Fze | ANALYSIS, MANUFACTURE | 2015-05-07 | 3 | 473350290, 473350289 | Caffeine Injectable Solution |
| 8 | d06d3810-9923-4199-be5e-ee5ee086b0a4 (view SPL) | Caffeine Citrate Injection, USP Caffeine Citrate Oral Solution, USP | prescription | Human Prescription | Sun Pharma Global Fze | ANALYSIS, MANUFACTURE | 2014-09-20 | 1 | 473350290, 473350289 | Caffeine Injectable Solution |
| 9 | dfa7e0a9-eac0-4741-9b85-69c122f13e33 (view SPL) | Caffeine Citrate Injection, USP Caffeine Citrate Oral Solution, USP | prescription | Human Prescription | Sun Pharmaceutical Industries Limited | analysis, manufacture | 2009-10-02 | 1 | 627560290, 627560289 | Caffeine Injectable Solution |
| 10 | fbcd234e-57e1-4da2-a96c-e3f7b7cf6ec0 (view SPL) | CAFCIT (caffeine citrate) Injection and CAFCIT (caffeine citrate) Oral Solution | prescription | Human Prescription | Bedford Laboratories | 2014-05-27 | 4 | 553900358, 553900357 | Caffeine Injectable Solution |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII