Application 215657

Type: ANDA
Sponsor: GLAND PHARMA LTD

Application Products#

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

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

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
A215657-001	LINCOMYCIN HYDROCHLORIDE	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP		2022-09-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215657-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`f41ea6bd6efb…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A215657-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215657-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215657-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215657-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215657-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215657-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215657-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215657-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215657-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215657-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215657-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215657-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215657-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215657-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215657-001	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215657-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215657-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215657-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215657-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215657-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215657-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215657-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215657-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215657-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215657-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215657-001	AP	1	`f41ea6bd6efb…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215657-001	AP	1	`a50c72e98297…`

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	Sagent Pharmaceuticals	75e149cc-b668-427e-bae7-a0d215e4fb7a	2023-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215657 application number: ANDA215657
lincomycin hydrochloride	LINCOMYCIN HYDROCHLORIDE	Gland Pharma Limited	c2b5be20-cc6f-4221-9d3e-3f8b5886cd05	2022-09-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215657 application number: ANDA215657 ndc (product): 68083-479 ndc (product): 68083-478

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68083-478	lincomycin hydrochloride	lincomycin hydrochloride	Gland Pharma Limited	ANDA	Current
68083-479	Lincomycin hydrochloride	lincomycin hydrochloride	Gland Pharma Limited	ANDA	Current