Application 050316
- Type
- NDA
- Sponsor
- PHARMACIA AND UPJOHN
Application Products#
| 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 |
Orange Book products#
| 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N050316-001 | LINCOCIN | EQ 250MG BASE | CAPSULE / ORAL | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N050316-002 | LINCOCIN | EQ 500MG BASE | CAPSULE / ORAL | Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N050316-001 | LINCOCIN | EQ 250MG BASE | CAPSULE / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N050316-002 | LINCOCIN | EQ 500MG BASE | CAPSULE / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050316-001 | LINCOCIN | EQ 250MG BASE | CAPSULE / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050316-002 | LINCOCIN | EQ 500MG BASE | CAPSULE / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050316-001 | LINCOCIN | EQ 250MG BASE | CAPSULE / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050316-002 | LINCOCIN | EQ 500MG BASE | CAPSULE / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N050316-001 | LINCOCIN | EQ 250MG BASE | CAPSULE / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N050316-002 | LINCOCIN | EQ 500MG BASE | CAPSULE / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050316-001 | LINCOCIN | EQ 250MG BASE | CAPSULE / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050316-002 | LINCOCIN | EQ 500MG BASE | CAPSULE / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050316-001 | LINCOCIN | EQ 250MG BASE | CAPSULE / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050316-002 | LINCOCIN | EQ 500MG BASE | CAPSULE / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050316-001 | LINCOCIN | EQ 250MG BASE | CAPSULE / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050316-002 | LINCOCIN | EQ 500MG BASE | CAPSULE / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050316-001 | LINCOCIN | EQ 250MG BASE | CAPSULE / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050316-002 | LINCOCIN | EQ 500MG BASE | CAPSULE / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050316-001 | LINCOCIN | EQ 250MG BASE | CAPSULE / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050316-002 | LINCOCIN | EQ 500MG BASE | CAPSULE / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050316-001 | LINCOCIN | EQ 250MG BASE | CAPSULE / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050316-002 | LINCOCIN | EQ 500MG BASE | CAPSULE / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N050316-001 | LINCOCIN | EQ 250MG BASE | CAPSULE / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N050316-002 | LINCOCIN | EQ 500MG BASE | CAPSULE / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050316-001 | LINCOCIN | EQ 250MG BASE | CAPSULE / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050316-002 | LINCOCIN | EQ 500MG BASE | CAPSULE / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050316-001 | LINCOCIN | EQ 250MG BASE | CAPSULE / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050316-002 | LINCOCIN | EQ 500MG BASE | CAPSULE / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050316-001 | LINCOCIN | EQ 250MG BASE | CAPSULE / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050316-002 | LINCOCIN | EQ 500MG BASE | CAPSULE / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N050316-001 | LINCOCIN | EQ 250MG BASE | CAPSULE / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N050316-002 | LINCOCIN | EQ 500MG BASE | CAPSULE / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050316-001 | LINCOCIN | EQ 250MG BASE | CAPSULE / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050316-002 | LINCOCIN | EQ 500MG BASE | CAPSULE / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N050316-001 | LINCOCIN | EQ 250MG BASE | CAPSULE / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N050316-002 | LINCOCIN | EQ 500MG BASE | CAPSULE / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N050316-001 | LINCOCIN | EQ 250MG BASE | CAPSULE / ORAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N050316-002 | LINCOCIN | EQ 500MG BASE | CAPSULE / ORAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 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… |
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.
| 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 | LINCOMYCIN HYDROCHLORIDE |
| Lincocin | LINCOMYCIN HYDROCHLORIDE | Pharmacia & Upjohn Company LLC | c01906fa-2c73-4c13-9765-2fd06628d263 | 2025-03-10 | Boxed warning, Warnings, Adverse reactions | Lincocin LINCOMYCIN HYDROCHLORIDE |
| Lincomycin | LINCOMYCIN HYDROCHLORIDE | PAI Holdings, LLC dba PAI Pharma | 23f9608c-3126-35db-e063-6294a90af054 | 2024-10-08 | Boxed warning, Warnings, Adverse reactions | LINCOMYCIN HYDROCHLORIDE |
| Lincomycin | LINCOMYCIN HYDROCHLORIDE | Sagent Pharmaceuticals | 75e149cc-b668-427e-bae7-a0d215e4fb7a | 2023-03-20 | Boxed warning, Warnings, Adverse reactions | LINCOMYCIN HYDROCHLORIDE |
| Lincomycin | LINCOMYCIN HYDROCHLORIDE | XGen Pharmaceuticals DJB, Inc. | 61f4851d-d919-400d-912a-05eb9dca11d4 | 2022-10-14 | Boxed warning, Warnings, Adverse reactions | LINCOMYCIN HYDROCHLORIDE |
| lincomycin hydrochloride | LINCOMYCIN HYDROCHLORIDE | Gland Pharma Limited | c2b5be20-cc6f-4221-9d3e-3f8b5886cd05 | 2022-09-28 | Boxed warning, Warnings, Adverse reactions | LINCOMYCIN HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 7726 | SUPPL | 2004-06-07 |