Application 060677
- Type
- ANDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TOTACILLIN-N | AMPICILLIN SODIUM | INJECTABLE;INJECTION | EQ 125MG BASE/VIAL | No | No |
| 002 | TOTACILLIN-N | AMPICILLIN SODIUM | INJECTABLE;INJECTION | EQ 250MG BASE/VIAL | No | No |
| 003 | TOTACILLIN-N | AMPICILLIN SODIUM | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | No |
| 004 | TOTACILLIN-N | AMPICILLIN SODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | No | No |
| 005 | TOTACILLIN-N | AMPICILLIN SODIUM | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL | No | No |
| 006 | TOTACILLIN-N | AMPICILLIN 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 |
|---|---|---|---|---|---|---|---|
| A060677-001 | TOTACILLIN-N | AMPICILLIN SODIUM | EQ 125MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | ||
| A060677-002 | TOTACILLIN-N | AMPICILLIN SODIUM | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | ||
| A060677-003 | TOTACILLIN-N | AMPICILLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | ||
| A060677-004 | TOTACILLIN-N | AMPICILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | ||
| A060677-005 | TOTACILLIN-N | AMPICILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | ||
| A060677-006 | TOTACILLIN-N | AMPICILLIN 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A060677-001 | TOTACILLIN-N | EQ 125MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A060677-002 | TOTACILLIN-N | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A060677-003 | TOTACILLIN-N | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A060677-004 | TOTACILLIN-N | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A060677-005 | TOTACILLIN-N | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A060677-006 | TOTACILLIN-N | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A060677-001 | TOTACILLIN-N | EQ 125MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A060677-002 | TOTACILLIN-N | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A060677-003 | TOTACILLIN-N | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A060677-004 | TOTACILLIN-N | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A060677-005 | TOTACILLIN-N | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A060677-006 | TOTACILLIN-N | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A060677-001 | TOTACILLIN-N | EQ 125MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A060677-002 | TOTACILLIN-N | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A060677-003 | TOTACILLIN-N | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A060677-004 | TOTACILLIN-N | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A060677-005 | TOTACILLIN-N | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A060677-006 | TOTACILLIN-N | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A060677-001 | TOTACILLIN-N | EQ 125MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A060677-002 | TOTACILLIN-N | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A060677-003 | TOTACILLIN-N | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A060677-004 | TOTACILLIN-N | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A060677-005 | TOTACILLIN-N | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A060677-006 | TOTACILLIN-N | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A060677-001 | TOTACILLIN-N | EQ 125MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A060677-002 | TOTACILLIN-N | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A060677-003 | TOTACILLIN-N | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A060677-004 | TOTACILLIN-N | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A060677-005 | TOTACILLIN-N | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A060677-006 | TOTACILLIN-N | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A060677-001 | TOTACILLIN-N | EQ 125MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A060677-002 | TOTACILLIN-N | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A060677-003 | TOTACILLIN-N | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A060677-004 | TOTACILLIN-N | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A060677-005 | TOTACILLIN-N | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A060677-006 | TOTACILLIN-N | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A060677-001 | TOTACILLIN-N | EQ 125MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A060677-002 | TOTACILLIN-N | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A060677-003 | TOTACILLIN-N | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A060677-004 | TOTACILLIN-N | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… |
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 | Medical Purchasing Solutions, LLC | 690f1986-6da9-4787-e053-2a91aa0a2644 | 2023-05-23 | Warnings, Adverse reactions | AMPICILLIN SODIUM |
| Ampicillin | AMPICILLIN SODIUM | Medical Purchasing Solutions, LLC | 70c022b0-ac9a-409b-e053-2a91aa0a757e | 2023-05-22 | Warnings, Adverse reactions | AMPICILLIN SODIUM |
| Ampicillin | AMPICILLIN SODIUM | Fresenius Kabi USA, LLC | 8dbb4c71-8543-08f1-e053-2995a90af88d | 2022-10-21 | Warnings, Adverse reactions | AMPICILLIN SODIUM |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.