Application 201720

Type: ANDA
Sponsor: SUN PHARM INDS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TESTOSTERONE CYPIONATE	TESTOSTERONE CYPIONATE	INJECTABLE;INJECTION	100MG/ML	No	No
002	TESTOSTERONE CYPIONATE	TESTOSTERONE CYPIONATE	INJECTABLE;INJECTION	200MG/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A201720-001	TESTOSTERONE CYPIONATE	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION			2013-06-03
A201720-002	TESTOSTERONE CYPIONATE	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION			2013-06-03

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 2 of 3 · 86 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
2022-03-09 01:35 UTC	2022-03	A201720-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201720-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201720-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201720-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201720-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201720-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201720-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A201720-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201720-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A201720-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201720-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A201720-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201720-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A201720-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201720-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201720-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201720-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201720-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201720-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201720-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201720-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A201720-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201720-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A201720-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201720-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201720-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201720-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201720-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201720-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201720-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201720-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201720-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201720-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A201720-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201720-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A201720-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201720-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201720-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201720-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A201720-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 64 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201720-001	AO	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201720-002	AO	1	`5bbf6a4d5a75…`
2024-10-29 15:01 UTC	2024-10	A201720-001	AO	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201720-002	AO	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201720-001	AO	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201720-002	AO	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201720-001	AO	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201720-002	AO	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201720-001	AO	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201720-002	AO	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201720-001	AO	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201720-002	AO	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201720-001	AO	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201720-002	AO	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201720-001	AO	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201720-002	AO	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201720-001	AO	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201720-002	AO	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201720-001	AO	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201720-002	AO	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201720-001	AO	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201720-002	AO	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201720-001	AO	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201720-002	AO	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201720-001	AO	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201720-002	AO	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201720-001	AO	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A201720-002	AO	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201720-001	AO	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A201720-002	AO	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201720-001	AO	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A201720-002	AO	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201720-001	AO	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A201720-002	AO	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201720-001	AO	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201720-002	AO	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201720-001	AO	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201720-002	AO	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201720-001	AO	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201720-002	AO	1	`6a51e52b5d6a…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Sun Pharmaceutical Industries, Inc.	3653a602-4551-4e6c-84a7-31861f5dc482	2025-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201720 application number: ANDA201720 ndc (product): 62756-017 ndc (product): 62756-016 ndc (product): 62756-015

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-4446	Testosterone Cypionate	Testosterone Cypionate	A-S Medication Solutions	ANDA	Current
50090-4446	Testosterone Cypionate	Testosterone Cypionate	A-S Medication Solutions	ANDA	Current
62756-015	Testosterone Cypionate	Testosterone Cypionate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-015	Testosterone Cypionate	Testosterone Cypionate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-015	Testosterone Cypionate	Testosterone Cypionate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-016	Testosterone Cypionate	Testosterone Cypionate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-016	Testosterone Cypionate	Testosterone Cypionate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-016	Testosterone Cypionate	Testosterone Cypionate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-017	Testosterone Cypionate	Testosterone Cypionate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-017	Testosterone Cypionate	Testosterone Cypionate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-017	Testosterone Cypionate	Testosterone Cypionate	Sun Pharmaceutical Industries, Inc.	ANDA	Current