Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091102
Company: SAGENT PHARMS
Company: SAGENT PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CAFFEINE CITRATE | CAFFEINE CITRATE | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | SOLUTION;ORAL | Prescription | AA | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
08/29/2012 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/02/2017 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
CAFFEINE CITRATE
SOLUTION;ORAL; EQ 30MG BASE/3ML (EQ 10MG BASE/ML)
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CAFFEINE CITRATE | CAFFEINE CITRATE | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | SOLUTION;ORAL | Prescription | No | AA | 077304 | EXELA PHARMA |
CAFFEINE CITRATE | CAFFEINE CITRATE | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | SOLUTION;ORAL | Prescription | No | AA | 078002 | FRESENIUS KABI USA |
CAFFEINE CITRATE | CAFFEINE CITRATE | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | SOLUTION;ORAL | Prescription | No | AA | 213202 | MICRO LABS |
CAFFEINE CITRATE | CAFFEINE CITRATE | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | SOLUTION;ORAL | Prescription | No | AA | 091102 | SAGENT PHARMS |
CAFFEINE CITRATE | CAFFEINE CITRATE | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | SOLUTION;ORAL | Prescription | No | AA | 090357 | SUN PHARM |