Application 061999
- Type
- ANDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NALLPEN | NAFCILLIN SODIUM | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | No |
| 002 | NALLPEN | NAFCILLIN SODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | No | No |
| 003 | NALLPEN | NAFCILLIN SODIUM | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL | No | No |
| 004 | NALLPEN | NAFCILLIN SODIUM | INJECTABLE;INJECTION | EQ 10GM BASE/VIAL | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A061999-001 | NALLPEN | NAFCILLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | ||
| A061999-002 | NALLPEN | NAFCILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | ||
| A061999-003 | NALLPEN | NAFCILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | ||
| A061999-004 | NALLPEN | NAFCILLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A061999-001 | NALLPEN | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A061999-002 | NALLPEN | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A061999-003 | NALLPEN | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A061999-004 | NALLPEN | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A061999-001 | NALLPEN | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A061999-002 | NALLPEN | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A061999-003 | NALLPEN | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A061999-004 | NALLPEN | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A061999-001 | NALLPEN | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A061999-002 | NALLPEN | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A061999-003 | NALLPEN | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A061999-004 | NALLPEN | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A061999-001 | NALLPEN | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A061999-002 | NALLPEN | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A061999-003 | NALLPEN | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A061999-004 | NALLPEN | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A061999-001 | NALLPEN | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A061999-002 | NALLPEN | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A061999-003 | NALLPEN | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A061999-004 | NALLPEN | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A061999-001 | NALLPEN | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A061999-002 | NALLPEN | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A061999-003 | NALLPEN | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A061999-004 | NALLPEN | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A061999-001 | NALLPEN | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A061999-002 | NALLPEN | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A061999-003 | NALLPEN | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A061999-004 | NALLPEN | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A061999-001 | NALLPEN | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A061999-002 | NALLPEN | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A061999-003 | NALLPEN | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A061999-004 | NALLPEN | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A061999-001 | NALLPEN | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A061999-002 | NALLPEN | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A061999-003 | NALLPEN | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A061999-004 | NALLPEN | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A061999-001 | NALLPEN | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A061999-002 | NALLPEN | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A061999-003 | NALLPEN | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A061999-004 | NALLPEN | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 4b0b4de00fa7… |
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 |
|---|---|---|---|---|---|---|
| Nafcillin | NAFCILLIN SODIUM | Heritage Pharmaceuticals Inc. d/b/a/ Avet Pharmaceuticals Inc. | 8a00624c-c436-4102-a042-dab54022bcc2 | 2026-07-28 | Warnings, Adverse reactions | NAFCILLIN SODIUM |
| NAFCILLIN SODIUM | NAFCILLIN SODIUM | ONESOURCE SPECIALTY PHARMA LIMITED | 4b3b8e52-df96-4886-e063-6294a90ac63f | 2026-03-09 | Warnings, Adverse reactions | NAFCILLIN SODIUM |
| NAFCILLIN SODIUM | NAFCILLIN SODIUM | Armas Pharmaceuticals Inc. | 090fda61-b9c8-640e-e063-6294a90a7363 | 2025-09-30 | Warnings, Adverse reactions | NAFCILLIN SODIUM |
| Nafcillin | NAFCILLIN SODIUM | Eugia US LLC | 90717878-64cb-4ffc-90bc-7b4e81e3d1cd | 2025-08-16 | Warnings, Adverse reactions | NAFCILLIN SODIUM |
| Nafcillin | NAFCILLIN SODIUM | Eugia US LLC | 8ec288e6-4d7f-4fea-a5ab-f9f337ebaa86 | 2025-08-16 | Warnings, Adverse reactions | NAFCILLIN SODIUM |
| Nafcillin | NAFCILLIN SODIUM | Eugia US LLC | 34821770-929c-40ea-a9e4-d4405dc869e1 | 2025-08-12 | Warnings, Adverse reactions | NAFCILLIN SODIUM |
| Nafcillin | NAFCILLIN SODIUM | Eugia US LLC | 0f21384c-0f82-4d99-a05c-6773d1ee4bcf | 2025-08-12 | Warnings, Adverse reactions | NAFCILLIN SODIUM |
| Nafcillin | NAFCILLIN SODIUM | Avenacy Inc. | 0556378a-b794-4235-ba09-ebdc295e9092 | 2025-02-01 | Warnings, Adverse reactions | NAFCILLIN SODIUM |
| Nafcillin | NAFCILLIN SODIUM | NorthStar Rx, LLC | ae5fb012-4012-4063-b2e4-f1f927c6bf74 | 2024-07-09 | Warnings, Adverse reactions | NAFCILLIN SODIUM |
| Nafcillin | NAFCILLIN SODIUM | Fresenius Kabi USA, LLC | 3c2581a1-8051-4d7a-a1f7-521248648dc9 | 2019-05-24 | Warnings, Adverse reactions | NAFCILLIN SODIUM |
| Nafcillin | NAFCILLIN SODIUM | Fresenius Kabi USA, LLC | c39721a3-7b22-4720-9dbd-bc82f03d2af7 | 2019-05-17 | Warnings, Adverse reactions | NAFCILLIN SODIUM |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.