Application 212301

Type: ANDA
Sponsor: FEMPHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TESTOSTERONE	TESTOSTERONE	SOLUTION, METERED;TRANSDERMAL	30MG/1.5ML ACTUATION	No	No

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

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
A212301-001	TESTOSTERONE	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT		2021-01-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A212301-001	AT

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 table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A212301-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-01-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212301-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-01-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212301-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-01-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212301-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-01-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212301-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-01-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212301-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-01-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212301-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-01-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212301-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-01-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212301-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-01-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212301-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-01-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212301-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-01-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212301-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-01-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212301-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-01-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212301-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-01-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212301-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-01-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212301-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-01-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212301-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-01-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212301-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-01-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212301-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-01-11	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212301-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-01-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212301-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-01-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212301-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-01-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212301-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-01-11	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212301-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-01-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212301-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-01-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212301-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-01-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212301-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-01-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212301-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-01-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212301-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-01-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212301-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-01-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212301-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-01-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212301-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-01-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212301-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-01-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212301-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-01-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212301-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-01-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212301-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-01-11	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212301-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-01-11	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A212301-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212301-001	AT	1	`caaa826d4ba7…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212301-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212301-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212301-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212301-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212301-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212301-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212301-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212301-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212301-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212301-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212301-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212301-001	AT	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212301-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212301-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212301-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212301-001	AT	1	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212301-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212301-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212301-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212301-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212301-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212301-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212301-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212301-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212301-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212301-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212301-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212301-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212301-001	AT	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212301-001	AT	1	`a50c72e98297…`

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	TESTOSTERONE	Encube Ethicals, Inc.	ca5d4865-356b-45e7-b603-fe299e450abc	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212301 application number: ANDA212301

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
69339-158	AXIRON	Testosterone	Dash Pharmaceuticals LLC	ANDA	Current
69339-158	Testosterone	Testosterone	Dash Pharmaceuticals LLC	ANDA	Current