Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090799
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | EQ 200MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | No |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | No |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | 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 |
|---|---|---|---|---|---|---|---|
| 07/25/2011 | ORIG-2 | Approval |
Label is not available on this site. |
||||
| 05/16/2011 | 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 |
|---|---|---|---|---|---|
| 10/06/2020 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/06/2020 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2017 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
GEMCITABINE HYDROCHLORIDE
INJECTABLE;INJECTION; EQ 200MG BASE/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | EQ 200MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 091365 | DR REDDYS LABS LTD |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | EQ 200MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 090799 | FRESENIUS KABI USA |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | EQ 200MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 204520 | GLAND PHARMA LTD |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | EQ 200MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 206617 | HIKMA INTL PHARMS |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | EQ 200MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 078339 | HOSPIRA |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | EQ 200MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 202485 | JIANGSU HANSOH PHARM |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | EQ 200MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 207575 | SHILPA |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | EQ 200MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 078433 | SUN PHARM |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | EQ 200MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 078759 | TEYRO LABS |
INJECTABLE;INJECTION; EQ 1GM BASE/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 091365 | DR REDDYS LABS LTD |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 090799 | FRESENIUS KABI USA |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 204520 | GLAND PHARMA LTD |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 206617 | HIKMA INTL PHARMS |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 078339 | HOSPIRA |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 202485 | JIANGSU HANSOH PHARM |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 207575 | SHILPA |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 078433 | SUN PHARM |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 078759 | TEYRO LABS |
INJECTABLE;INJECTION; EQ 2GM BASE/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 202997 | DR REDDYS LABS LTD |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 090242 | FRESENIUS KABI USA |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 090799 | FRESENIUS KABI USA |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 079183 | HOSPIRA INC |