Application 050309
- Type
- NDA
- Sponsor
- BRISTOL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | POLYCILLIN-N | AMPICILLIN SODIUM | INJECTABLE;INJECTION | EQ 125MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 002 | POLYCILLIN-N | AMPICILLIN SODIUM | INJECTABLE;INJECTION | EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 003 | POLYCILLIN-N | AMPICILLIN SODIUM | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 004 | POLYCILLIN-N | AMPICILLIN SODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 005 | POLYCILLIN-N | AMPICILLIN SODIUM | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050309-001 | POLYCILLIN-N | AMPICILLIN SODIUM | EQ 125MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | Approved before 1982 | ||
| N050309-002 | POLYCILLIN-N | AMPICILLIN SODIUM | EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | Approved before 1982 | ||
| N050309-003 | POLYCILLIN-N | AMPICILLIN SODIUM | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | Approved before 1982 | ||
| N050309-004 | POLYCILLIN-N | AMPICILLIN SODIUM | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | Approved before 1982 | ||
| N050309-005 | POLYCILLIN-N | AMPICILLIN SODIUM | EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-05-31 18:47 UTC | 2024-05 | N050309-001 | POLYCILLIN-N | EQ 125MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N050309-002 | POLYCILLIN-N | EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N050309-003 | POLYCILLIN-N | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N050309-004 | POLYCILLIN-N | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N050309-005 | POLYCILLIN-N | EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050309-001 | POLYCILLIN-N | EQ 125MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050309-002 | POLYCILLIN-N | EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050309-003 | POLYCILLIN-N | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050309-004 | POLYCILLIN-N | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050309-005 | POLYCILLIN-N | EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N050309-001 | POLYCILLIN-N | EQ 125MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N050309-002 | POLYCILLIN-N | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N050309-003 | POLYCILLIN-N | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N050309-004 | POLYCILLIN-N | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N050309-005 | POLYCILLIN-N | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N050309-001 | POLYCILLIN-N | EQ 125MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N050309-002 | POLYCILLIN-N | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N050309-003 | POLYCILLIN-N | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N050309-004 | POLYCILLIN-N | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N050309-005 | POLYCILLIN-N | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N050309-001 | POLYCILLIN-N | EQ 125MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N050309-002 | POLYCILLIN-N | EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N050309-003 | POLYCILLIN-N | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N050309-004 | POLYCILLIN-N | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N050309-005 | POLYCILLIN-N | EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N050309-001 | POLYCILLIN-N | EQ 125MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | Approved before 1982 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N050309-002 | POLYCILLIN-N | EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | Approved before 1982 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N050309-003 | POLYCILLIN-N | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | Approved before 1982 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N050309-004 | POLYCILLIN-N | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | Approved before 1982 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N050309-005 | POLYCILLIN-N | EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N050309-001 | POLYCILLIN-N | EQ 125MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | Approved before 1982 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N050309-002 | POLYCILLIN-N | EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | Approved before 1982 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N050309-003 | POLYCILLIN-N | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | Approved before 1982 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N050309-004 | POLYCILLIN-N | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | Approved before 1982 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N050309-005 | POLYCILLIN-N | EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | Approved before 1982 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N050309-001 | POLYCILLIN-N | EQ 125MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | Approved before 1982 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N050309-002 | POLYCILLIN-N | EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | Approved before 1982 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N050309-003 | POLYCILLIN-N | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | Approved before 1982 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N050309-004 | POLYCILLIN-N | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | Approved before 1982 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N050309-005 | POLYCILLIN-N | EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | Approved before 1982 | 87673890dc5c… |
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 |
|---|---|---|---|---|---|---|
| AMPICILLIN | AMPICILLIN SODIUM | Henry Schein, Inc. | 78988f6a-a73b-4d3b-9a76-d61a748c3c16 | 2026-07-31 | Warnings, Adverse reactions | AMPICILLIN SODIUM |
| Ampicillin Sodium | AMPICILLIN SODIUM | Sagent Pharmaceuticals | 5b3796dd-6f81-4999-ae2b-a13a72795729 | 2026-07-27 | Warnings, Adverse reactions | AMPICILLIN SODIUM |
| Ampicillin | AMPICILLIN SODIUM | NorthStar Rx, LLC | 3b683547-48ac-48ca-8fd4-6866fd17be34 | 2026-06-15 | Warnings, Adverse reactions | AMPICILLIN SODIUM |
| AMPICILLIN | AMPICILLIN SODIUM | Henry Schein, Inc. | 06ca924c-5f3a-4924-90f4-5ba623daaa0e | 2026-04-30 | Warnings, Adverse reactions | AMPICILLIN SODIUM |
| Ampicillin sodium | AMPICILLIN SODIUM | Medical Purchasing Solutions, LLC | 402e7cc7-5ae8-c113-e063-6394a90aa54a | 2025-10-02 | Warnings, Adverse reactions | AMPICILLIN SODIUM |
| Ampicillin | AMPICILLIN SODIUM | Eugia US LLC | b7bf2897-8272-4c7d-84e9-6fbba0ea63fa | 2025-08-14 | Warnings, Adverse reactions | AMPICILLIN SODIUM |
| Ampicillin | AMPICILLIN SODIUM | Eugia US LLC | 66146d45-0fe4-46b9-b2b1-b67c219088b7 | 2025-08-14 | Warnings, Adverse reactions | AMPICILLIN SODIUM |
| Ampicillin | AMPICILLIN | Armas Pharmaceuticals Inc. | 34e95c91-3767-493c-8716-38e61e7c6674 | 2025-07-31 | Warnings, Adverse reactions | AMPICILLIN SODIUM |
| Ampicillin | AMPICILLIN SODIUM | ProPharma Distribution | 364b1db9-e523-7bae-e063-6294a90a651d | 2025-07-18 | Warnings, Adverse reactions | AMPICILLIN SODIUM |
| Ampicillin sodium | AMPICILLIN | Civica, Inc. | 2fd0f9fa-5b86-42f7-9a9f-767123638d39 | 2025-06-30 | Warnings, Adverse reactions | AMPICILLIN SODIUM |
| Ampicillin | AMPICILLIN SODIUM | Sandoz Inc | 67dd2930-8482-4da5-b663-b751aff18c61 | 2025-05-16 | Warnings, Adverse reactions | AMPICILLIN SODIUM |
| Ampicillin | AMPICILLIN SODIUM | Sandoz Inc | 64a04e8c-8f78-46b3-8f45-56ef225a4f74 | 2025-02-21 | Warnings, Adverse reactions | AMPICILLIN SODIUM |
| Ampicillin | AMPICILLIN SODIUM | Avenacy Inc. | 19546563-50b7-4160-8cbe-f8e7079cba69 | 2025-02-01 | Warnings, Adverse reactions | AMPICILLIN SODIUM |
| Ampicillin | AMPICILLIN SODIUM | Sandoz Inc | c2908a44-1da4-4885-ae5a-23f69189d91a | 2024-10-31 | Warnings, Adverse reactions | AMPICILLIN SODIUM |
| Ampicillin | AMPICILLIN SODIUM | Sandoz Inc | b371e1a5-1fef-4df2-8940-c4fc02b9e2f0 | 2024-10-31 | Warnings, Adverse reactions | AMPICILLIN SODIUM |
| Ampicillin | AMPICILLIN SODIUM | Sandoz Inc | 5308ddfa-4a5b-4f7b-83ce-9d1b528e050d | 2024-05-09 | Warnings, Adverse reactions | AMPICILLIN SODIUM |
| Ampicillin | AMPICILLIN SODIUM | Sandoz Inc | 6632a5bd-45f1-422f-80b0-46e5a628969a | 2024-05-08 | Warnings, Adverse reactions | AMPICILLIN SODIUM |
| Ampicillin | AMPICILLIN SODIUM | Sandoz Inc | f77db491-31c4-4a7c-a114-0f3244c97090 | 2024-05-07 | Warnings, Adverse reactions | AMPICILLIN SODIUM |
| Ampicillin | AMPICILLIN SODIUM | NorthStar Rx, LLC | 6772d650-9814-49e4-a4ec-0b1a97b837d1 | 2024-02-22 | Warnings, Adverse reactions | AMPICILLIN SODIUM |
| Ampicillin | AMPICILLIN SODIUM | Medical Purchasing Solutions, LLC | 690f1986-6da9-4787-e053-2a91aa0a2644 | 2023-05-23 | Warnings, Adverse reactions | AMPICILLIN SODIUM |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.