Application 201746

Type: ANDA
Sponsor: XGEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LINCOMYCIN	LINCOMYCIN HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 300MG BASE/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A201746-001	LINCOMYCIN HYDROCHLORIDE	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP		2015-06-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201746-001	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 1 of 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A201746-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2015-06-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201746-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2015-06-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201746-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2015-06-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201746-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2015-06-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201746-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2015-06-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201746-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2015-06-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201746-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2015-06-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201746-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2015-06-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201746-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2015-06-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201746-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2015-06-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201746-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2015-06-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201746-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2015-06-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201746-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2015-06-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201746-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2015-06-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201746-001	LINCOMYCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2015-06-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201746-001	LINCOMYCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2015-06-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201746-001	LINCOMYCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2015-06-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201746-001	LINCOMYCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2015-06-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201746-001	LINCOMYCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2015-06-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201746-001	LINCOMYCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2015-06-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201746-001	LINCOMYCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2015-06-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201746-001	LINCOMYCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2015-06-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201746-001	LINCOMYCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2015-06-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201746-001	LINCOMYCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2015-06-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201746-001	LINCOMYCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2015-06-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201746-001	LINCOMYCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2015-06-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201746-001	LINCOMYCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2015-06-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201746-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2015-06-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201746-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2015-06-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201746-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2015-06-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201746-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2015-06-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201746-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2015-06-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201746-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2015-06-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201746-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2015-06-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201746-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2015-06-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201746-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2015-06-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201746-001	LINCOMYCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2015-06-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201746-001	LINCOMYCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2015-06-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201746-001	LINCOMYCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2015-06-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201746-001	LINCOMYCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2015-06-04	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201746-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201746-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201746-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201746-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201746-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201746-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201746-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201746-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201746-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201746-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201746-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201746-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201746-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201746-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201746-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201746-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201746-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201746-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201746-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201746-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201746-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201746-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201746-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201746-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201746-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201746-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201746-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201746-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201746-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201746-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201746-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201746-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201746-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201746-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201746-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201746-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201746-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201746-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201746-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201746-001	AP	1	`cb3db0bc1861…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LINCOMYCIN	LINCOMYCIN HYDROCHLORIDE	Henry Schein, Inc.	a7692968-7ac8-48ab-89a4-27c7803e31f4	2025-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201746 application number: ANDA201746 ndc (product): 0404-9901
Lincomycin	LINCOMYCIN HYDROCHLORIDE	XGen Pharmaceuticals DJB, Inc.	61f4851d-d919-400d-912a-05eb9dca11d4	2022-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201746 application number: ANDA201746 ndc (product): 39822-0353 ndc (product): 39822-0350

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9901	LINCOMYCIN	lincomycin hydrochloride	Henry Schein, Inc.	ANDA	Current
0404-9901	LINCOMYCIN	lincomycin hydrochloride	Henry Schein, Inc.	ANDA	Current
39822-0350	Lincomycin	lincomycin hydrochloride	XGen Pharmaceuticals DJB, Inc.	ANDA	Current
39822-0350	Lincomycin	lincomycin hydrochloride	X-GEN Pharmaceuticals, Inc.	ANDA	Current
39822-0350	Lincomycin	lincomycin hydrochloride	X-GEN Pharmaceuticals, Inc.	ANDA	Current
39822-0350	Lincomycin	lincomycin hydrochloride	X-GEN Pharmaceuticals, Inc.	ANDA	Current
39822-0350	Lincomycin	lincomycin hydrochloride	XGen Pharmaceuticals DJB, Inc.	ANDA	Current
39822-0353	Lincomycin	lincomycin hydrochloride	XGen Pharmaceuticals DJB, Inc.	ANDA	Current
39822-0353	Lincomycin	lincomycin hydrochloride	X-GEN Pharmaceuticals, Inc.	ANDA	Current
39822-0353	Lincomycin	lincomycin hydrochloride	X-GEN Pharmaceuticals, Inc.	ANDA	Current
39822-0353	Lincomycin	lincomycin hydrochloride	X-GEN Pharmaceuticals, Inc.	ANDA	Current
39822-0353	Lincomycin	lincomycin hydrochloride	XGen Pharmaceuticals DJB, Inc.	ANDA	Current
50090-4533	Lincomycin	lincomycin hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4533	Lincomycin	lincomycin hydrochloride	A-S Medication Solutions	ANDA	Current
52584-353	LINCOMYCIN	lincomycin hydrochloride	General Injectables and Vaccines, INC.	ANDA	Current
52584-353	LINCOMYCIN	lincomycin hydrochloride	General Injectables and Vaccines, INC.	ANDA	Current
52584-353	LINCOMYCIN	lincomycin hydrochloride	General Injectables and Vaccines, INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
32136	ORIG	2015-06-10