Application 208313

Type: NDA
Sponsor: SUN PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	INFUGEM	GEMCITABINE HYDROCHLORIDE	SOLUTION;INTRAVENOUS	EQ 1200MG BASE/120ML (EQ 10MG BASE/ML)	Yes	Yes
002	INFUGEM	GEMCITABINE HYDROCHLORIDE	SOLUTION;INTRAVENOUS	EQ 1300MG BASE/130ML (EQ 10MG BASE/ML)	Yes	Yes
003	INFUGEM	GEMCITABINE HYDROCHLORIDE	SOLUTION;INTRAVENOUS	EQ 1400MG BASE/140ML (EQ 10MG BASE/ML)	Yes	Yes
004	INFUGEM	GEMCITABINE HYDROCHLORIDE	SOLUTION;INTRAVENOUS	EQ 1500MG BASE/150ML (EQ 10MG BASE/ML)	Yes	Yes
005	INFUGEM	GEMCITABINE HYDROCHLORIDE	SOLUTION;INTRAVENOUS	EQ 1600MG BASE/160ML (EQ 10MG BASE/ML)	Yes	Yes
006	INFUGEM	GEMCITABINE HYDROCHLORIDE	SOLUTION;INTRAVENOUS	EQ 1700MG BASE/170ML (EQ 10MG BASE/ML)	Yes	Yes
007	INFUGEM	GEMCITABINE HYDROCHLORIDE	SOLUTION;INTRAVENOUS	EQ 1800MG BASE/180ML (EQ 10MG BASE/ML)	Yes	Yes
008	INFUGEM	GEMCITABINE HYDROCHLORIDE	SOLUTION;INTRAVENOUS	EQ 1900MG BASE/190ML (EQ 10MG BASE/ML)	Yes	Yes
009	INFUGEM	GEMCITABINE HYDROCHLORIDE	SOLUTION;INTRAVENOUS	EQ 2000MG BASE/200ML (EQ 10MG BASE/ML)	Yes	Yes
010	INFUGEM	GEMCITABINE HYDROCHLORIDE	SOLUTION;INTRAVENOUS	EQ 2200MG BASE/220ML (EQ 10MG BASE/ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 10 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N208313-001	INFUGEM	GEMCITABINE HYDROCHLORIDE	EQ 1200MG BASE/120ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16
N208313-002	INFUGEM	GEMCITABINE HYDROCHLORIDE	EQ 1300MG BASE/130ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16
N208313-003	INFUGEM	GEMCITABINE HYDROCHLORIDE	EQ 1400MG BASE/140ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16
N208313-004	INFUGEM	GEMCITABINE HYDROCHLORIDE	EQ 1500MG BASE/150ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16
N208313-005	INFUGEM	GEMCITABINE HYDROCHLORIDE	EQ 1600MG BASE/160ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16
N208313-006	INFUGEM	GEMCITABINE HYDROCHLORIDE	EQ 1700MG BASE/170ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16
N208313-007	INFUGEM	GEMCITABINE HYDROCHLORIDE	EQ 1800MG BASE/180ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16
N208313-008	INFUGEM	GEMCITABINE HYDROCHLORIDE	EQ 1900MG BASE/190ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16
N208313-009	INFUGEM	GEMCITABINE HYDROCHLORIDE	EQ 2000MG BASE/200ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16
N208313-010	INFUGEM	GEMCITABINE HYDROCHLORIDE	EQ 2200MG BASE/220ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16

Orange Book patents#

Current patent rows page 1 of 1 · 10 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N208313-001	9241948	2033-07-01	Drug product	2018-07-25
N208313-002	9241948	2033-07-01	Drug product	2018-07-25
N208313-003	9241948	2033-07-01	Drug product	2018-07-25
N208313-004	9241948	2033-07-01	Drug product	2018-07-25
N208313-005	9241948	2033-07-01	Drug product	2018-07-25
N208313-006	9241948	2033-07-01	Drug product	2018-07-25
N208313-007	9241948	2033-07-01	Drug product	2018-07-25
N208313-008	9241948	2033-07-01	Drug product	2018-07-25
N208313-009	9241948	2033-07-01	Drug product	2018-07-25
N208313-010	9241948	2033-07-01	Drug product	2018-07-25

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 11 · 420 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N208313-001	INFUGEM	EQ 1200MG BASE/120ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208313-002	INFUGEM	EQ 1300MG BASE/130ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208313-003	INFUGEM	EQ 1400MG BASE/140ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208313-004	INFUGEM	EQ 1500MG BASE/150ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208313-005	INFUGEM	EQ 1600MG BASE/160ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208313-006	INFUGEM	EQ 1700MG BASE/170ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208313-007	INFUGEM	EQ 1800MG BASE/180ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208313-008	INFUGEM	EQ 1900MG BASE/190ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208313-009	INFUGEM	EQ 2000MG BASE/200ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208313-010	INFUGEM	EQ 2200MG BASE/220ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208313-001	INFUGEM	EQ 1200MG BASE/120ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208313-002	INFUGEM	EQ 1300MG BASE/130ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208313-003	INFUGEM	EQ 1400MG BASE/140ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208313-004	INFUGEM	EQ 1500MG BASE/150ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208313-005	INFUGEM	EQ 1600MG BASE/160ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208313-006	INFUGEM	EQ 1700MG BASE/170ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208313-007	INFUGEM	EQ 1800MG BASE/180ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208313-008	INFUGEM	EQ 1900MG BASE/190ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208313-009	INFUGEM	EQ 2000MG BASE/200ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208313-010	INFUGEM	EQ 2200MG BASE/220ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208313-001	INFUGEM	EQ 1200MG BASE/120ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208313-002	INFUGEM	EQ 1300MG BASE/130ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208313-003	INFUGEM	EQ 1400MG BASE/140ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208313-004	INFUGEM	EQ 1500MG BASE/150ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208313-005	INFUGEM	EQ 1600MG BASE/160ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208313-006	INFUGEM	EQ 1700MG BASE/170ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208313-007	INFUGEM	EQ 1800MG BASE/180ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208313-008	INFUGEM	EQ 1900MG BASE/190ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208313-009	INFUGEM	EQ 2000MG BASE/200ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208313-010	INFUGEM	EQ 2200MG BASE/220ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208313-001	INFUGEM	EQ 1200MG BASE/120ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208313-002	INFUGEM	EQ 1300MG BASE/130ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208313-003	INFUGEM	EQ 1400MG BASE/140ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208313-004	INFUGEM	EQ 1500MG BASE/150ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208313-005	INFUGEM	EQ 1600MG BASE/160ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208313-006	INFUGEM	EQ 1700MG BASE/170ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208313-007	INFUGEM	EQ 1800MG BASE/180ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208313-008	INFUGEM	EQ 1900MG BASE/190ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208313-009	INFUGEM	EQ 2000MG BASE/200ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208313-010	INFUGEM	EQ 2200MG BASE/220ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-07-16	`6a471c1ec25d…`

Observed Orange Book patent history#

Patent history page 1 of 11 · 420 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N208313-001	9241948	2033-07-01	Drug product	2018-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208313-002	9241948	2033-07-01	Drug product	2018-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208313-003	9241948	2033-07-01	Drug product	2018-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208313-004	9241948	2033-07-01	Drug product	2018-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208313-005	9241948	2033-07-01	Drug product	2018-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208313-006	9241948	2033-07-01	Drug product	2018-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208313-007	9241948	2033-07-01	Drug product	2018-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208313-008	9241948	2033-07-01	Drug product	2018-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208313-009	9241948	2033-07-01	Drug product	2018-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208313-010	9241948	2033-07-01	Drug product	2018-07-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208313-001	9241948	2033-07-01	Drug product	2018-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208313-002	9241948	2033-07-01	Drug product	2018-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208313-003	9241948	2033-07-01	Drug product	2018-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208313-004	9241948	2033-07-01	Drug product	2018-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208313-005	9241948	2033-07-01	Drug product	2018-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208313-006	9241948	2033-07-01	Drug product	2018-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208313-007	9241948	2033-07-01	Drug product	2018-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208313-008	9241948	2033-07-01	Drug product	2018-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208313-009	9241948	2033-07-01	Drug product	2018-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208313-010	9241948	2033-07-01	Drug product	2018-07-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208313-001	9241948	2033-07-01	Drug product	2018-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208313-002	9241948	2033-07-01	Drug product	2018-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208313-003	9241948	2033-07-01	Drug product	2018-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208313-004	9241948	2033-07-01	Drug product	2018-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208313-005	9241948	2033-07-01	Drug product	2018-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208313-006	9241948	2033-07-01	Drug product	2018-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208313-007	9241948	2033-07-01	Drug product	2018-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208313-008	9241948	2033-07-01	Drug product	2018-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208313-009	9241948	2033-07-01	Drug product	2018-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208313-010	9241948	2033-07-01	Drug product	2018-07-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208313-001	9241948	2033-07-01	Drug product	2018-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208313-002	9241948	2033-07-01	Drug product	2018-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208313-003	9241948	2033-07-01	Drug product	2018-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208313-004	9241948	2033-07-01	Drug product	2018-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208313-005	9241948	2033-07-01	Drug product	2018-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208313-006	9241948	2033-07-01	Drug product	2018-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208313-007	9241948	2033-07-01	Drug product	2018-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208313-008	9241948	2033-07-01	Drug product	2018-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208313-009	9241948	2033-07-01	Drug product	2018-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208313-010	9241948	2033-07-01	Drug product	2018-07-25	`6a471c1ec25d…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gemcitabine	GEMCITABINE HYDROCHLORIDE	Meitheal Pharmaceuticals Inc.	c0b1b715-9ff8-43ca-9e49-465f1f380084	2025-07-23	Warnings, Adverse reactions	Name fallback generic name: GEMCITABINE HYDROCHLORIDE
GEMCITABINE	GEMCITABINE HYDROCHLORIDE	NorthStar Rx LLC	5af49a48-f1c0-467d-b5da-ac9f1ae8e34c	2025-02-03	Warnings, Adverse reactions	Name fallback generic name: GEMCITABINE HYDROCHLORIDE
GEMCITABINE	GEMCITABINE HYDROCHLORIDE	Meitheal Pharmaceuticals Inc.	a5949d02-29eb-4626-ad35-b7614bb0fa95	2025-01-29	Warnings, Adverse reactions	Name fallback generic name: GEMCITABINE HYDROCHLORIDE
Gemcitabine hydrochloride	GEMCITABINE HYDROCHLORIDE	Teyro Labs Private Limited	a6ddaa2f-4c17-430f-a7cd-96b6662923f6	2025-01-09	Warnings, Adverse reactions	Name fallback generic name: GEMCITABINE HYDROCHLORIDE
Gemcitabine	GEMCITABINE HYDROCHLORIDE	Mylan Institutional LLC	06dd9d40-74fc-4409-93b1-a46be7126331	2024-11-11	Warnings, Adverse reactions	Name fallback generic name: GEMCITABINE HYDROCHLORIDE
gemcitabine hydrochloride	GEMCITABINE HYDROCHLORIDE	Gland Pharma Limited	9f8fe5ba-943f-4f0a-9618-6083101faa28	2024-09-06	Warnings, Adverse reactions	Name fallback generic name: GEMCITABINE HYDROCHLORIDE
gemcitabine	GEMCITABINE HYDROCHLORIDE	Sagent Pharmaceuticals	44bcc16c-341d-49e8-a1c6-95d084667aca	2024-09-06	Warnings, Adverse reactions	Name fallback generic name: GEMCITABINE HYDROCHLORIDE
Gemcitabine	GEMCITABINE HYDROCHLORIDE	Meitheal Pharmaceuticals Inc.	73ae04d8-38f9-4d3d-b0c2-71d22af1fc86	2024-08-05	Warnings, Adverse reactions	Name fallback generic name: GEMCITABINE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62756-008	INFUGEM	gemcitabine	Sun Pharmaceutical Industries, Inc.	NDA	Current
62756-008	INFUGEM	gemcitabine	Sun Pharmaceutical Industries, Inc.	NDA	Current
62756-008	INFUGEM	gemcitabine	Sun Pharmaceutical Industries, Inc.	NDA	Current
62756-073	INFUGEM	gemcitabine	Sun Pharmaceutical Industries, Inc.	NDA	Current
62756-073	INFUGEM	gemcitabine	Sun Pharmaceutical Industries, Inc.	NDA	Current
62756-073	INFUGEM	gemcitabine	Sun Pharmaceutical Industries, Inc.	NDA	Current
62756-102	INFUGEM	gemcitabine	Sun Pharmaceutical Industries, Inc.	NDA	Current
62756-102	INFUGEM	gemcitabine	Sun Pharmaceutical Industries, Inc.	NDA	Current
62756-102	INFUGEM	gemcitabine	Sun Pharmaceutical Industries, Inc.	NDA	Current
62756-219	INFUGEM	gemcitabine	Sun Pharmaceutical Industries, Inc.	NDA	Current
62756-219	INFUGEM	gemcitabine	Sun Pharmaceutical Industries, Inc.	NDA	Current
62756-219	INFUGEM	gemcitabine	Sun Pharmaceutical Industries, Inc.	NDA	Current
62756-321	INFUGEM	gemcitabine	Sun Pharmaceutical Industries, Inc.	NDA	Current
62756-321	INFUGEM	gemcitabine	Sun Pharmaceutical Industries, Inc.	NDA	Current
62756-321	INFUGEM	gemcitabine	Sun Pharmaceutical Industries, Inc.	NDA	Current
62756-438	INFUGEM	gemcitabine	Sun Pharmaceutical Industries, Inc.	NDA	Current
62756-438	INFUGEM	gemcitabine	Sun Pharmaceutical Industries, Inc.	NDA	Current
62756-438	INFUGEM	gemcitabine	Sun Pharmaceutical Industries, Inc.	NDA	Current
62756-533	INFUGEM	gemcitabine	Sun Pharmaceutical Industries, Inc.	NDA	Current
62756-533	INFUGEM	gemcitabine	Sun Pharmaceutical Industries, Inc.	NDA	Current
62756-533	INFUGEM	gemcitabine	Sun Pharmaceutical Industries, Inc.	NDA	Current
62756-614	INFUGEM	gemcitabine	Sun Pharmaceutical Industries, Inc.	NDA	Current
62756-614	INFUGEM	gemcitabine	Sun Pharmaceutical Industries, Inc.	NDA	Current
62756-614	INFUGEM	gemcitabine	Sun Pharmaceutical Industries, Inc.	NDA	Current
62756-746	INFUGEM	gemcitabine	Sun Pharmaceutical Industries, Inc.	NDA	Current
62756-746	INFUGEM	gemcitabine	Sun Pharmaceutical Industries, Inc.	NDA	Current
62756-746	INFUGEM	gemcitabine	Sun Pharmaceutical Industries, Inc.	NDA	Current
62756-974	INFUGEM	gemcitabine	Sun Pharmaceutical Industries, Inc.	NDA	Current
62756-974	INFUGEM	gemcitabine	Sun Pharmaceutical Industries, Inc.	NDA	Current
62756-974	INFUGEM	gemcitabine	Sun Pharmaceutical Industries, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79738	SUPPL	2024-09-26
79733	SUPPL	2024-09-26
61547	SUPPL	2020-01-10
61538	SUPPL	2020-01-09
58300	ORIG	2019-04-12
54953	ORIG	2018-10-26
54908	ORIG	2018-07-17