Application 213175

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	INJECTABLE;INJECTION	200MG/5.26ML (38MG/ML)	No	No
002	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	INJECTABLE;INJECTION	1GM/26.3ML (38MG/ML)	No	No
003	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	INJECTABLE;INJECTION	2GM/52.6ML (38MG/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A213175-001	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2023-03-07
A213175-002	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2023-03-07
A213175-003	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2023-03-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A213175-001	AP
A213175-002	AP
A213175-003	AP

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 2 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213175-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2023-03-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213175-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2023-03-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213175-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2023-03-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213175-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2023-03-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213175-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2023-03-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213175-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2023-03-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213175-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2023-03-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213175-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2023-03-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213175-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2023-03-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213175-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2023-03-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213175-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2023-03-07	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213175-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2023-03-07	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213175-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2023-03-07	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213175-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2023-03-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213175-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2023-03-07	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A213175-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2023-03-07	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A213175-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2023-03-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213175-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2023-03-07	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A213175-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2023-03-07	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A213175-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2023-03-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213175-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2023-03-07	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213175-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2023-03-07	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213175-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2023-03-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213175-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2023-03-07	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213175-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2023-03-07	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213175-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2023-03-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213175-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2023-03-07	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213175-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2023-03-07	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213175-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2023-03-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213175-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2023-03-07	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213175-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2023-03-07	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213175-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2023-03-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213175-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2023-03-07	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A213175-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2023-03-07	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A213175-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2023-03-07	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213175-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2023-03-07	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213175-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2023-03-07	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213175-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2023-03-07	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A213175-001	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A213175-002	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A213175-003	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A213175-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213175-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213175-003	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213175-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213175-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213175-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213175-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213175-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213175-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213175-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213175-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213175-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213175-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213175-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213175-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213175-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213175-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213175-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213175-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213175-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213175-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213175-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213175-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213175-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213175-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213175-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213175-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213175-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213175-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213175-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213175-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213175-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213175-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213175-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213175-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213175-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213175-001	AP	1	`79d66fd596c7…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gemcitabine	GEMCITABINE	Hikma Pharmaceuticals USA Inc.	d80176fe-3e8b-48be-87c2-9c603013b3fa	2025-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213175 application number: ANDA213175

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.