Application 210303
- Type
- NDA
- Sponsor
- CIPLA USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZEMDRI | PLAZOMICIN SULFATE | SOLUTION;INTRAVENOUS | EQ 500MG BASE/10ML (EQ 50MG BASE/ML) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N210303-001 | ZEMDRI | PLAZOMICIN SULFATE | EQ 500MG BASE/10ML (EQ 50MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD | 2018-06-25 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N210303-001 | 8822424 | 2028-11-21 | Drug product | 2018-07-19 | |
| N210303-001 | 9266919 | 2028-11-21 | U-2328 | 2018-07-19 | |
| N210303-001 | 9688711 | 2028-11-21 | U-2328 | Drug substance | 2018-07-19 |
| N210303-001 | 8383596 | 2032-06-25 | U-2328 | Drug substance | 2018-07-19 |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| N210303-001 | NCE | 2023-06-25 |
| N210303-001 | GAIN | 2028-06-25 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | N210303-001 | ZEMDRI | EQ 500MG BASE/10ML (EQ 50MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2018-06-25 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N210303-001 | ZEMDRI | EQ 500MG BASE/10ML (EQ 50MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2018-06-25 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N210303-001 | ZEMDRI | EQ 500MG BASE/10ML (EQ 50MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2018-06-25 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N210303-001 | ZEMDRI | EQ 500MG BASE/10ML (EQ 50MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD | 2018-06-25 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N210303-001 | 8822424 | 2028-11-21 | Drug product | 2018-07-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N210303-001 | 9266919 | 2028-11-21 | U-2328 | 2018-07-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N210303-001 | 9688711 | 2028-11-21 | U-2328 | Drug substance | 2018-07-19 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N210303-001 | 8383596 | 2032-06-25 | U-2328 | Drug substance | 2018-07-19 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | N210303-001 | 8822424 | 2028-11-21 | Drug product | 2018-07-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N210303-001 | 9266919 | 2028-11-21 | U-2328 | 2018-07-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N210303-001 | 9688711 | 2028-11-21 | U-2328 | Drug substance | 2018-07-19 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N210303-001 | 8383596 | 2032-06-25 | U-2328 | Drug substance | 2018-07-19 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N210303-001 | 8822424 | 2028-11-21 | Drug product | 2018-07-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N210303-001 | 9266919 | 2028-11-21 | U-2328 | 2018-07-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N210303-001 | 9688711 | 2028-11-21 | U-2328 | Drug substance | 2018-07-19 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N210303-001 | 8383596 | 2032-06-25 | U-2328 | Drug substance | 2018-07-19 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N210303-001 | 8822424 | 2028-11-21 | Drug product | 2018-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210303-001 | 9266919 | 2028-11-21 | U-2328 | 2018-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210303-001 | 9688711 | 2028-11-21 | U-2328 | Drug substance | 2018-07-19 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N210303-001 | 8383596 | 2032-06-25 | U-2328 | Drug substance | 2018-07-19 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210303-001 | 8822424 | 2028-11-21 | Drug product | 2018-07-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210303-001 | 9266919 | 2028-11-21 | U-2328 | 2018-07-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210303-001 | 9688711 | 2028-11-21 | U-2328 | Drug substance | 2018-07-19 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210303-001 | 8383596 | 2031-06-02 | U-2328 | Drug substance | 2018-07-19 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N210303-001 | 8822424 | 2028-11-21 | Drug product | 2018-07-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N210303-001 | 9266919 | 2028-11-21 | U-2328 | 2018-07-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N210303-001 | 9688711 | 2028-11-21 | U-2328 | Drug substance | 2018-07-19 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N210303-001 | 8383596 | 2031-06-02 | U-2328 | Drug substance | 2018-07-19 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210303-001 | 8822424 | 2028-11-21 | Drug product | 2018-07-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210303-001 | 9266919 | 2028-11-21 | U-2328 | 2018-07-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210303-001 | 9688711 | 2028-11-21 | U-2328 | Drug substance | 2018-07-19 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210303-001 | 8383596 | 2031-06-02 | U-2328 | Drug substance | 2018-07-19 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210303-001 | 8822424 | 2028-11-21 | Drug product | 2018-07-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210303-001 | 9266919 | 2028-11-21 | U-2328 | 2018-07-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210303-001 | 9688711 | 2028-11-21 | U-2328 | Drug substance | 2018-07-19 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210303-001 | 8383596 | 2031-06-02 | U-2328 | Drug substance | 2018-07-19 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N210303-001 | 8822424 | 2028-11-21 | Drug product | 2018-07-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N210303-001 | 9266919 | 2028-11-21 | U-2328 | 2018-07-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N210303-001 | 9688711 | 2028-11-21 | U-2328 | Drug substance | 2018-07-19 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N210303-001 | 8383596 | 2031-06-02 | U-2328 | Drug substance | 2018-07-19 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N210303-001 | 8822424 | 2028-11-21 | Drug product | 2018-07-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N210303-001 | 9266919 | 2028-11-21 | U-2328 | 2018-07-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N210303-001 | 9688711 | 2028-11-21 | U-2328 | Drug substance | 2018-07-19 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N210303-001 | 8383596 | 2031-06-02 | U-2328 | Drug substance | 2018-07-19 | 2680178bc6a6… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N210303-001 | NCE | 2023-06-25 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N210303-001 | GAIN | 2028-06-25 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | N210303-001 | NCE | 2023-06-25 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N210303-001 | GAIN | 2028-06-25 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N210303-001 | NCE | 2023-06-25 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N210303-001 | GAIN | 2028-06-25 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N210303-001 | NCE | 2023-06-25 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N210303-001 | GAIN | 2028-06-25 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210303-001 | NCE | 2023-06-25 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210303-001 | GAIN | 2028-06-25 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N210303-001 | NCE | 2023-06-25 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N210303-001 | GAIN | 2028-06-25 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210303-001 | NCE | 2023-06-25 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210303-001 | GAIN | 2028-06-25 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210303-001 | NCE | 2023-06-25 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210303-001 | GAIN | 2028-06-25 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N210303-001 | NCE | 2023-06-25 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N210303-001 | GAIN | 2028-06-25 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N210303-001 | NCE | 2023-06-25 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N210303-001 | GAIN | 2028-06-25 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N210303-001 | NCE | 2023-06-25 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N210303-001 | GAIN | 2028-06-25 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N210303-001 | NCE | 2023-06-25 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N210303-001 | GAIN | 2028-06-25 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N210303-001 | NCE | 2023-06-25 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N210303-001 | GAIN | 2028-06-25 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N210303-001 | NCE | 2023-06-25 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N210303-001 | GAIN | 2028-06-25 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N210303-001 | NCE | 2023-06-25 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N210303-001 | GAIN | 2028-06-25 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N210303-001 | NCE | 2023-06-25 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N210303-001 | GAIN | 2028-06-25 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N210303-001 | NCE | 2023-06-25 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N210303-001 | GAIN | 2028-06-25 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N210303-001 | NCE | 2023-06-25 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N210303-001 | GAIN | 2028-06-25 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N210303-001 | NCE | 2023-06-25 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N210303-001 | GAIN | 2028-06-25 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N210303-001 | NCE | 2023-06-25 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N210303-001 | GAIN | 2028-06-25 | 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 |
|---|---|---|---|---|---|---|
| Zemdri (plazomicin) | PLAZOMICIN | Cipla USA Inc. | eccf9fd9-53ac-4252-a106-5567b3a82a70 | 2024-12-20 | Boxed warning, Warnings, Adverse reactions | 210303 NDA210303 69097-820 |
| Zemdri (plazomicin) | PLAZOMICIN | Cipla Therapeutics Inc. | 1243fcd3-de84-428b-901e-d83d65e4d98c | 2023-02-27 | Boxed warning, Warnings, Adverse reactions | 210303 NDA210303 80735-820 |
| Zemdri (plazomicin) | PLAZOMICIN | Achaogen, Inc. | 0b82ffed-27f4-4f5c-8135-670c148f0e12 | 2018-06-29 | Boxed warning, Warnings, Adverse reactions | 210303 NDA210303 71045-010 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 69097-820 | Zemdri (plazomicin) | Plazomicin | Cipla USA Inc. | NDA | Current |
| 69097-820 | Zemdri (plazomicin) | Plazomicin | Cipla USA Inc. | NDA | Current |
| 71045-010 | Zemdri (plazomicin) | Plazomicin | Achaogen, Inc. | NDA | Current |
| 80735-820 | Zemdri (plazomicin) | Plazomicin | Cipla Therapeutics Inc. | NDA | Current |