Application 201166

Type: ANDA
Sponsor: MEITHEAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TOPOTECAN HYDROCHLORIDE	TOPOTECAN HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 4MG BASE/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A201166-001	TOPOTECAN HYDROCHLORIDE	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION			2012-08-08

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 · 41 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
2026-02-19 14:30 UTC	2026-02	A201166-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION		2012-08-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201166-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION		2012-08-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201166-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION		2012-08-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201166-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION		2012-08-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201166-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION		2012-08-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201166-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION		2012-08-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201166-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION		2012-08-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201166-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION		2012-08-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201166-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION		2012-08-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201166-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION		2012-08-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201166-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION		2012-08-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201166-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION		2012-08-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201166-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION		2012-08-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201166-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION		2012-08-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201166-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION		2012-08-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201166-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION		2012-08-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201166-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION		2012-08-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201166-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201166-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION		2012-08-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201166-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION		2012-08-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201166-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201166-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201166-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201166-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201166-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201166-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201166-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201166-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION		2012-08-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201166-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION		2012-08-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201166-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION		2012-08-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201166-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION		2012-08-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201166-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION		2012-08-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201166-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION		2012-08-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201166-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION		2012-08-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201166-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION		2012-08-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201166-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION		2012-08-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201166-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION		2012-08-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201166-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION		2012-08-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201166-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION		2012-08-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201166-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION		2012-08-08	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A201166-001	AP	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201166-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201166-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201166-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201166-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201166-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201166-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201166-001	AP	1	`ea99ee380514…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Topotecan Hydrochloride	TOPOTECAN HYDROCHLORIDE	Fresenius Kabi USA, LLC	b6019088-cd94-43b4-b5ce-ba20b6b8021e	2026-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Topotecan Hydrochloride generic name: TOPOTECAN HYDROCHLORIDE
topotecan hydrochloride	TOPOTECAN HYDROCHLORIDE	Accord Healthcare, Inc.	729b2b22-1344-44f3-b614-14f6ec3c263e	2024-10-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: topotecan hydrochloride generic name: TOPOTECAN HYDROCHLORIDE
Topotecan hydrochloride	TOPOTECAN HYDROCHLORIDE	Actavis Pharma, Inc.	996430c0-ee26-4ed9-82b8-a8b645becba6	2022-08-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Topotecan hydrochloride generic name: TOPOTECAN HYDROCHLORIDE
HYCAMTIN	TOPOTECAN HYDROCHLORIDE	Novartis Pharmaceuticals Corporation	eeee060c-a9ec-423e-a374-8484009f8524	2022-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOPOTECAN HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71288-127	Topotecan	Topotecan Hydrochloride	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-127	Topotecan	Topotecan Hydrochloride	Meitheal Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22846	ORIG	2013-02-26