Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209077
Company: SAGENT PHARMS INC
Company: SAGENT PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 200MG/5.26ML (38MG/ML) | INJECTABLE;INJECTION | Prescription | AP | No | No |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 1GM/26.3ML (38MG/ML) | INJECTABLE;INJECTION | Prescription | AP | No | No |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 2GM/52.6ML (38MG/ML) | 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 |
|---|---|---|---|---|---|---|---|
| 07/20/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/04/2020 | SUPPL-3 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
GEMCITABINE HYDROCHLORIDE
INJECTABLE;INJECTION; 200MG/5.26ML (38MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 200MG/5.26ML (38MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 213175 | HIKMA |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 200MG/5.26ML (38MG/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 200795 | HOSPIRA INC |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 200MG/5.26ML (38MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 212129 | MEITHEAL |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 200MG/5.26ML (38MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 205242 | MYLAN LABS LTD |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 200MG/5.26ML (38MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 210383 | NOVAST LABS |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 200MG/5.26ML (38MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 209077 | SAGENT PHARMS INC |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 200MG/5.26ML (38MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 210991 | SHILPA |
INJECTABLE;INJECTION; 1GM/26.3ML (38MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 1GM/26.3ML (38MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 213175 | HIKMA |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 1GM/26.3ML (38MG/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 200795 | HOSPIRA INC |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 1GM/26.3ML (38MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 212129 | MEITHEAL |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 1GM/26.3ML (38MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 205242 | MYLAN LABS LTD |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 1GM/26.3ML (38MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 210383 | NOVAST LABS |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 1GM/26.3ML (38MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 209077 | SAGENT PHARMS INC |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 1GM/26.3ML (38MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 210991 | SHILPA |
INJECTABLE;INJECTION; 2GM/52.6ML (38MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 2GM/52.6ML (38MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 213175 | HIKMA |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 2GM/52.6ML (38MG/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 200795 | HOSPIRA INC |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 2GM/52.6ML (38MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 212129 | MEITHEAL |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 2GM/52.6ML (38MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 205242 | MYLAN LABS LTD |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 2GM/52.6ML (38MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 210383 | NOVAST LABS |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 2GM/52.6ML (38MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 209077 | SAGENT PHARMS INC |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 2GM/52.6ML (38MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 210991 | SHILPA |