Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078759
Company: TEYRO LABS
Company: TEYRO LABS
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 |
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-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 |
---|---|---|---|---|---|
10/17/2019 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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05/03/2019 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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05/03/2019 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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05/03/2019 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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06/23/2016 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
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12/02/2015 | SUPPL-1 | Manufacturing (CMC) |
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 | 091594 | ACCORD HLTHCARE |
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 | 091594 | ACCORD HLTHCARE |
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 |