Application 065033

Type: ANDA
Sponsor: TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BLEOMYCIN SULFATE	BLEOMYCIN SULFATE	INJECTABLE;INJECTION	EQ 15 UNITS BASE/VIAL	No	No
002	BLEOMYCIN SULFATE	BLEOMYCIN SULFATE	INJECTABLE;INJECTION	EQ 30 UNITS BASE/VIAL	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065033-001	BLEOMYCIN SULFATE	BLEOMYCIN SULFATE	EQ 15 UNITS BASE/VIAL	INJECTABLE / INJECTION			2000-06-27
A065033-002	BLEOMYCIN SULFATE	BLEOMYCIN SULFATE	EQ 30 UNITS BASE/VIAL	INJECTABLE / INJECTION			2000-06-27

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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A065033-001	BLEOMYCIN SULFATE	EQ 15 UNITS BASE/VIAL	INJECTABLE / INJECTION		2000-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065033-002	BLEOMYCIN SULFATE	EQ 30 UNITS BASE/VIAL	INJECTABLE / INJECTION		2000-06-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065033-001	BLEOMYCIN SULFATE	EQ 15 UNITS BASE/VIAL	INJECTABLE / INJECTION		2000-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065033-002	BLEOMYCIN SULFATE	EQ 30 UNITS BASE/VIAL	INJECTABLE / INJECTION		2000-06-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065033-001	BLEOMYCIN SULFATE	EQ 15 UNITS BASE/VIAL	INJECTABLE / INJECTION		2000-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065033-002	BLEOMYCIN SULFATE	EQ 30 UNITS BASE/VIAL	INJECTABLE / INJECTION		2000-06-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065033-001	BLEOMYCIN SULFATE	EQ 15 UNITS BASE/VIAL	INJECTABLE / INJECTION		2000-06-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065033-002	BLEOMYCIN SULFATE	EQ 30 UNITS BASE/VIAL	INJECTABLE / INJECTION		2000-06-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065033-001	BLEOMYCIN SULFATE	EQ 15 UNITS BASE/VIAL	INJECTABLE / INJECTION		2000-06-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065033-002	BLEOMYCIN SULFATE	EQ 30 UNITS BASE/VIAL	INJECTABLE / INJECTION		2000-06-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065033-001	BLEOMYCIN SULFATE	EQ 15 UNITS BASE/VIAL	INJECTABLE / INJECTION		2000-06-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065033-002	BLEOMYCIN SULFATE	EQ 30 UNITS BASE/VIAL	INJECTABLE / INJECTION		2000-06-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065033-001	BLEOMYCIN SULFATE	EQ 15 UNITS BASE/VIAL	INJECTABLE / INJECTION		2000-06-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065033-002	BLEOMYCIN SULFATE	EQ 30 UNITS BASE/VIAL	INJECTABLE / INJECTION		2000-06-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065033-001	BLEOMYCIN SULFATE	EQ 15 UNITS BASE/VIAL	INJECTABLE / INJECTION		2000-06-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065033-002	BLEOMYCIN SULFATE	EQ 30 UNITS BASE/VIAL	INJECTABLE / INJECTION		2000-06-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065033-001	BLEOMYCIN SULFATE	EQ 15 UNITS BASE/VIAL	INJECTABLE / INJECTION		2000-06-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065033-002	BLEOMYCIN SULFATE	EQ 30 UNITS BASE/VIAL	INJECTABLE / INJECTION		2000-06-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065033-001	BLEOMYCIN SULFATE	EQ 15 UNITS BASE/VIAL	INJECTABLE / INJECTION		2000-06-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065033-002	BLEOMYCIN SULFATE	EQ 30 UNITS BASE/VIAL	INJECTABLE / INJECTION		2000-06-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065033-001	BLEOMYCIN SULFATE	EQ 15 UNITS BASE/VIAL	INJECTABLE / INJECTION		2000-06-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065033-002	BLEOMYCIN SULFATE	EQ 30 UNITS BASE/VIAL	INJECTABLE / INJECTION		2000-06-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065033-001	BLEOMYCIN SULFATE	EQ 15 UNITS BASE/VIAL	INJECTABLE / INJECTION		2000-06-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065033-002	BLEOMYCIN SULFATE	EQ 30 UNITS BASE/VIAL	INJECTABLE / INJECTION		2000-06-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065033-001	BLEOMYCIN SULFATE	EQ 15 UNITS BASE/VIAL	INJECTABLE / INJECTION		2000-06-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065033-002	BLEOMYCIN SULFATE	EQ 30 UNITS BASE/VIAL	INJECTABLE / INJECTION		2000-06-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065033-001	BLEOMYCIN SULFATE	EQ 15 UNITS BASE/VIAL	INJECTABLE / INJECTION		2000-06-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065033-002	BLEOMYCIN SULFATE	EQ 30 UNITS BASE/VIAL	INJECTABLE / INJECTION		2000-06-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065033-001	BLEOMYCIN SULFATE	EQ 15 UNITS BASE/VIAL	INJECTABLE / INJECTION		2000-06-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065033-002	BLEOMYCIN SULFATE	EQ 30 UNITS BASE/VIAL	INJECTABLE / INJECTION		2000-06-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065033-001	BLEOMYCIN SULFATE	EQ 15 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2000-06-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065033-002	BLEOMYCIN SULFATE	EQ 30 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2000-06-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065033-001	BLEOMYCIN SULFATE	EQ 15 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2000-06-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065033-002	BLEOMYCIN SULFATE	EQ 30 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2000-06-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065033-001	BLEOMYCIN SULFATE	EQ 15 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2000-06-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065033-002	BLEOMYCIN SULFATE	EQ 30 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2000-06-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065033-001	BLEOMYCIN SULFATE	EQ 15 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2000-06-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065033-002	BLEOMYCIN SULFATE	EQ 30 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2000-06-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065033-001	BLEOMYCIN SULFATE	EQ 15 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2000-06-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065033-002	BLEOMYCIN SULFATE	EQ 30 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2000-06-27	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065033-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065033-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065033-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065033-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065033-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065033-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065033-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065033-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065033-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065033-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065033-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065033-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065033-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065033-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065033-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A065033-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065033-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A065033-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065033-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A065033-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065033-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A065033-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065033-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A065033-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065033-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A065033-002	AP	1	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	A065033-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A065033-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065033-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065033-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065033-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065033-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065033-001	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065033-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065033-001	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065033-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065033-001	AP	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A065033-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065033-001	AP	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A065033-002	AP	1	`3bdfa0b2c4d7…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bleomycin	BLEOMYCIN SULFATE	Meitheal Pharmaceuticals Inc.	640602f9-a7df-46f0-a9b1-19c471008bee	2026-04-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BLEOMYCIN SULFATE
Bleomycin	BLEOMYCIN SULFATE	Fresenius Kabi USA, LLC	b5806c40-12ce-48e3-8abd-9f8997ef4428	2024-10-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BLEOMYCIN SULFATE

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
0703-3154	Bleomycin	Bleomycin	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-3154	Bleomycin	Bleomycin	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-3155	Bleomycin	Bleomycin	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-3155	Bleomycin	Bleomycin	Teva Parenteral Medicines, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8375	ORIG	2000-06-27