Application 050317

Type: NDA
Sponsor: PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LINCOCIN	LINCOMYCIN HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 300MG BASE/ML	Yes	Yes

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
N050317-001	LINCOCIN	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N050317-001	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	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050317-001	LINCOCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050317-001	LINCOCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050317-001	LINCOCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050317-001	LINCOCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050317-001	LINCOCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050317-001	LINCOCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050317-001	LINCOCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050317-001	LINCOCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050317-001	LINCOCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050317-001	LINCOCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050317-001	LINCOCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050317-001	LINCOCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050317-001	LINCOCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050317-001	LINCOCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050317-001	LINCOCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050317-001	LINCOCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050317-001	LINCOCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050317-001	LINCOCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050317-001	LINCOCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050317-001	LINCOCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050317-001	LINCOCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050317-001	LINCOCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050317-001	LINCOCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050317-001	LINCOCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050317-001	LINCOCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050317-001	LINCOCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050317-001	LINCOCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050317-001	LINCOCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050317-001	LINCOCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050317-001	LINCOCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050317-001	LINCOCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050317-001	LINCOCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050317-001	LINCOCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050317-001	LINCOCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050317-001	LINCOCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050317-001	LINCOCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050317-001	LINCOCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050317-001	LINCOCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050317-001	LINCOCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050317-001	LINCOCIN	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`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	N050317-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050317-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050317-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050317-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050317-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050317-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050317-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050317-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050317-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050317-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050317-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050317-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050317-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050317-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050317-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050317-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050317-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050317-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050317-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050317-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050317-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050317-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050317-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050317-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050317-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050317-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050317-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050317-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050317-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050317-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050317-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050317-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050317-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050317-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050317-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050317-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050317-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050317-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050317-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050317-001	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lincocin	LINCOMYCIN HYDROCHLORIDE	Pharmacia & Upjohn Company LLC	c01906fa-2c73-4c13-9765-2fd06628d263	2025-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 050317 application number: NDA050317 ndc (product): 0009-0555

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0009-0555	Lincocin	lincomycin hydrochloride	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0555	Lincocin	lincomycin hydrochloride	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0555	Lincocin	lincomycin hydrochloride	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0555	Lincocin	lincomycin hydrochloride	Pharmacia & Upjohn Company LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
70755	SUPPL	2022-04-12
70754	SUPPL	2022-04-12
56693	SUPPL	2018-12-07
56512	SUPPL	2018-11-20
53590	SUPPL	2018-04-02
53589	SUPPL	2018-04-02
45874	SUPPL	2016-11-10
45873	SUPPL	2016-11-10
45868	SUPPL	2016-11-10
45867	SUPPL	2016-11-10
7728	SUPPL	2014-10-21
17818	SUPPL	2014-10-16
30004	SUPPL	2008-02-29
38926	SUPPL	2008-02-28
7727	SUPPL	2004-06-07