Application 050316

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	CAPSULE;ORAL	EQ 250MG BASE	No	No
002	LINCOCIN	LINCOMYCIN HYDROCHLORIDE	CAPSULE;ORAL	EQ 500MG BASE	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N050316-001	LINCOCIN	LINCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL		Approved before 1982
N050316-002	LINCOCIN	LINCOMYCIN HYDROCHLORIDE	EQ 500MG BASE	CAPSULE / ORAL		Approved before 1982

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 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N050316-001	LINCOCIN	EQ 250MG BASE	CAPSULE / ORAL	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050316-002	LINCOCIN	EQ 500MG BASE	CAPSULE / ORAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050316-001	LINCOCIN	EQ 250MG BASE	CAPSULE / ORAL	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050316-002	LINCOCIN	EQ 500MG BASE	CAPSULE / ORAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050316-001	LINCOCIN	EQ 250MG BASE	CAPSULE / ORAL	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050316-002	LINCOCIN	EQ 500MG BASE	CAPSULE / ORAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050316-001	LINCOCIN	EQ 250MG BASE	CAPSULE / ORAL	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050316-002	LINCOCIN	EQ 500MG BASE	CAPSULE / ORAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050316-001	LINCOCIN	EQ 250MG BASE	CAPSULE / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050316-002	LINCOCIN	EQ 500MG BASE	CAPSULE / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050316-001	LINCOCIN	EQ 250MG BASE	CAPSULE / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050316-002	LINCOCIN	EQ 500MG BASE	CAPSULE / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050316-001	LINCOCIN	EQ 250MG BASE	CAPSULE / ORAL	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050316-002	LINCOCIN	EQ 500MG BASE	CAPSULE / ORAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050316-001	LINCOCIN	EQ 250MG BASE	CAPSULE / ORAL	Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050316-002	LINCOCIN	EQ 500MG BASE	CAPSULE / ORAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050316-001	LINCOCIN	EQ 250MG BASE	CAPSULE / ORAL	Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050316-002	LINCOCIN	EQ 500MG BASE	CAPSULE / ORAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050316-001	LINCOCIN	EQ 250MG BASE	CAPSULE / ORAL	Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050316-002	LINCOCIN	EQ 500MG BASE	CAPSULE / ORAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050316-001	LINCOCIN	EQ 250MG BASE	CAPSULE / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050316-002	LINCOCIN	EQ 500MG BASE	CAPSULE / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050316-001	LINCOCIN	EQ 250MG BASE	CAPSULE / ORAL	Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N050316-002	LINCOCIN	EQ 500MG BASE	CAPSULE / ORAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050316-001	LINCOCIN	EQ 250MG BASE	CAPSULE / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N050316-002	LINCOCIN	EQ 500MG BASE	CAPSULE / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050316-001	LINCOCIN	EQ 250MG BASE	CAPSULE / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050316-002	LINCOCIN	EQ 500MG BASE	CAPSULE / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050316-001	LINCOCIN	EQ 250MG BASE	CAPSULE / ORAL	Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050316-002	LINCOCIN	EQ 500MG BASE	CAPSULE / ORAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050316-001	LINCOCIN	EQ 250MG BASE	CAPSULE / ORAL	Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050316-002	LINCOCIN	EQ 500MG BASE	CAPSULE / ORAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050316-001	LINCOCIN	EQ 250MG BASE	CAPSULE / ORAL	Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050316-002	LINCOCIN	EQ 500MG BASE	CAPSULE / ORAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050316-001	LINCOCIN	EQ 250MG BASE	CAPSULE / ORAL	Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N050316-002	LINCOCIN	EQ 500MG BASE	CAPSULE / ORAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050316-001	LINCOCIN	EQ 250MG BASE	CAPSULE / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N050316-002	LINCOCIN	EQ 500MG BASE	CAPSULE / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050316-001	LINCOCIN	EQ 250MG BASE	CAPSULE / ORAL	Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050316-002	LINCOCIN	EQ 500MG BASE	CAPSULE / ORAL	Approved before 1982	`3a93d1ddd44b…`

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 · 6 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	Name fallback generic name: LINCOMYCIN HYDROCHLORIDE
Lincocin	LINCOMYCIN HYDROCHLORIDE	Pharmacia & Upjohn Company LLC	c01906fa-2c73-4c13-9765-2fd06628d263	2025-03-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lincocin generic name: LINCOMYCIN HYDROCHLORIDE
Lincomycin	LINCOMYCIN HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	23f9608c-3126-35db-e063-6294a90af054	2024-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LINCOMYCIN HYDROCHLORIDE
Lincomycin	LINCOMYCIN HYDROCHLORIDE	Sagent Pharmaceuticals	75e149cc-b668-427e-bae7-a0d215e4fb7a	2023-03-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LINCOMYCIN HYDROCHLORIDE
Lincomycin	LINCOMYCIN HYDROCHLORIDE	XGen Pharmaceuticals DJB, Inc.	61f4851d-d919-400d-912a-05eb9dca11d4	2022-10-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LINCOMYCIN HYDROCHLORIDE
lincomycin hydrochloride	LINCOMYCIN HYDROCHLORIDE	Gland Pharma Limited	c2b5be20-cc6f-4221-9d3e-3f8b5886cd05	2022-09-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LINCOMYCIN HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
7726	SUPPL	2004-06-07