Application 210303

Type: NDA
Sponsor: CIPLA USA

Application Products#

Product, Drug, Ingredient table
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
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#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
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#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N210303-001	ZEMDRI	EQ 500MG BASE/10ML (EQ 50MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2018-06-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210303-001	ZEMDRI	EQ 500MG BASE/10ML (EQ 50MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-06-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210303-001	ZEMDRI	EQ 500MG BASE/10ML (EQ 50MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-06-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210303-001	ZEMDRI	EQ 500MG BASE/10ML (EQ 50MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-06-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210303-001	ZEMDRI	EQ 500MG BASE/10ML (EQ 50MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-06-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210303-001	ZEMDRI	EQ 500MG BASE/10ML (EQ 50MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-06-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210303-001	ZEMDRI	EQ 500MG BASE/10ML (EQ 50MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-06-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210303-001	ZEMDRI	EQ 500MG BASE/10ML (EQ 50MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-06-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210303-001	ZEMDRI	EQ 500MG BASE/10ML (EQ 50MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-06-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210303-001	ZEMDRI	EQ 500MG BASE/10ML (EQ 50MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-06-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210303-001	ZEMDRI	EQ 500MG BASE/10ML (EQ 50MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-06-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210303-001	ZEMDRI	EQ 500MG BASE/10ML (EQ 50MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-06-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210303-001	ZEMDRI	EQ 500MG BASE/10ML (EQ 50MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-06-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210303-001	ZEMDRI	EQ 500MG BASE/10ML (EQ 50MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-06-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210303-001	ZEMDRI	EQ 500MG BASE/10ML (EQ 50MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-06-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210303-001	ZEMDRI	EQ 500MG BASE/10ML (EQ 50MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-06-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210303-001	ZEMDRI	EQ 500MG BASE/10ML (EQ 50MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-06-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210303-001	ZEMDRI	EQ 500MG BASE/10ML (EQ 50MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-06-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210303-001	ZEMDRI	EQ 500MG BASE/10ML (EQ 50MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-06-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210303-001	ZEMDRI	EQ 500MG BASE/10ML (EQ 50MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-06-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210303-001	ZEMDRI	EQ 500MG BASE/10ML (EQ 50MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-06-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210303-001	ZEMDRI	EQ 500MG BASE/10ML (EQ 50MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-06-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210303-001	ZEMDRI	EQ 500MG BASE/10ML (EQ 50MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-06-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210303-001	ZEMDRI	EQ 500MG BASE/10ML (EQ 50MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-06-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210303-001	ZEMDRI	EQ 500MG BASE/10ML (EQ 50MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-06-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210303-001	ZEMDRI	EQ 500MG BASE/10ML (EQ 50MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-06-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N210303-001	ZEMDRI	EQ 500MG BASE/10ML (EQ 50MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-06-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N210303-001	ZEMDRI	EQ 500MG BASE/10ML (EQ 50MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-06-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N210303-001	ZEMDRI	EQ 500MG BASE/10ML (EQ 50MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-06-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N210303-001	ZEMDRI	EQ 500MG BASE/10ML (EQ 50MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-06-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N210303-001	ZEMDRI	EQ 500MG BASE/10ML (EQ 50MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-06-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N210303-001	ZEMDRI	EQ 500MG BASE/10ML (EQ 50MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-06-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N210303-001	ZEMDRI	EQ 500MG BASE/10ML (EQ 50MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-06-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N210303-001	ZEMDRI	EQ 500MG BASE/10ML (EQ 50MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-06-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N210303-001	ZEMDRI	EQ 500MG BASE/10ML (EQ 50MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-06-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N210303-001	ZEMDRI	EQ 500MG BASE/10ML (EQ 50MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-06-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N210303-001	ZEMDRI	EQ 500MG BASE/10ML (EQ 50MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-06-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N210303-001	ZEMDRI	EQ 500MG BASE/10ML (EQ 50MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-06-25	`3a93d1ddd44b…`
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…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
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…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210303-001	8822424	2028-11-21		Drug product	2018-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210303-001	9266919	2028-11-21	U-2328		2018-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210303-001	9688711	2028-11-21	U-2328	Drug substance	2018-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210303-001	8383596	2031-06-02	U-2328	Drug substance	2018-07-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210303-001	8822424	2028-11-21		Drug product	2018-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210303-001	9266919	2028-11-21	U-2328		2018-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210303-001	9688711	2028-11-21	U-2328	Drug substance	2018-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210303-001	8383596	2031-06-02	U-2328	Drug substance	2018-07-19	`d8e5a09893c0…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
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…`
2019-12-13 00:20 UTC	2019-12	N210303-001	NCE	2023-06-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N210303-001	GAIN	2028-06-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210303-001	NCE	2023-06-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210303-001	GAIN	2028-06-25	`bb7c543d1eb4…`

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.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
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	Exact identifier application applno (NDA): 210303 application number: NDA210303 ndc (product): 69097-820
Zemdri (plazomicin)	PLAZOMICIN	Cipla Therapeutics Inc.	1243fcd3-de84-428b-901e-d83d65e4d98c	2023-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 210303 application number: NDA210303 ndc (product): 80735-820
Zemdri (plazomicin)	PLAZOMICIN	Achaogen, Inc.	0b82ffed-27f4-4f5c-8135-670c148f0e12	2018-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 210303 application number: NDA210303 ndc (product): 71045-010

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73474	SUPPL	2023-02-13
73468	SUPPL	2023-02-13
63969	SUPPL	2020-07-20
55017	ORIG	2018-07-27
54683	ORIG	2018-06-26
54682	ORIG	2018-06-26