Application 080256

Type: ANDA
Sponsor: LILLY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHYLTESTOSTERONE	METHYLTESTOSTERONE	TABLET;BUCCAL, SUBLINGUAL	10MG	No	No
002	METHYLTESTOSTERONE	METHYLTESTOSTERONE	TABLET;BUCCAL, SUBLINGUAL	25MG	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
A080256-001	METHYLTESTOSTERONE	METHYLTESTOSTERONE	10MG	TABLET / BUCCAL, SUBLINGUAL		Approved before 1982
A080256-002	METHYLTESTOSTERONE	METHYLTESTOSTERONE	25MG	TABLET / BUCCAL, SUBLINGUAL		Approved before 1982

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	RLD / RS	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A080256-001	METHYLTESTOSTERONE	10MG	TABLET / BUCCAL, SUBLINGUAL	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A080256-002	METHYLTESTOSTERONE	25MG	TABLET / BUCCAL, SUBLINGUAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080256-001	METHYLTESTOSTERONE	10MG	TABLET / BUCCAL, SUBLINGUAL	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A080256-002	METHYLTESTOSTERONE	25MG	TABLET / BUCCAL, SUBLINGUAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080256-001	METHYLTESTOSTERONE	10MG	TABLET / BUCCAL, SUBLINGUAL	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080256-002	METHYLTESTOSTERONE	25MG	TABLET / BUCCAL, SUBLINGUAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080256-001	METHYLTESTOSTERONE	10MG	TABLET / BUCCAL, SUBLINGUAL	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A080256-002	METHYLTESTOSTERONE	25MG	TABLET / BUCCAL, SUBLINGUAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080256-001	METHYLTESTOSTERONE	10MG	TABLET / BUCCAL, SUBLINGUAL	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A080256-002	METHYLTESTOSTERONE	25MG	TABLET / BUCCAL, SUBLINGUAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080256-001	METHYLTESTOSTERONE	10MG	TABLET / BUCCAL, SUBLINGUAL	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A080256-002	METHYLTESTOSTERONE	25MG	TABLET / BUCCAL, SUBLINGUAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080256-001	METHYLTESTOSTERONE	10MG	TABLET / BUCCAL, SUBLINGUAL	Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A080256-002	METHYLTESTOSTERONE	25MG	TABLET / BUCCAL, SUBLINGUAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080256-001	METHYLTESTOSTERONE	10MG	TABLET / BUCCAL, SUBLINGUAL	Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A080256-002	METHYLTESTOSTERONE	25MG	TABLET / BUCCAL, SUBLINGUAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080256-001	METHYLTESTOSTERONE	10MG	TABLET / BUCCAL, SUBLINGUAL	Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A080256-002	METHYLTESTOSTERONE	25MG	TABLET / BUCCAL, SUBLINGUAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080256-001	METHYLTESTOSTERONE	10MG	TABLET / BUCCAL, SUBLINGUAL	Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080256-002	METHYLTESTOSTERONE	25MG	TABLET / BUCCAL, SUBLINGUAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080256-001	METHYLTESTOSTERONE	10MG	TABLET / BUCCAL, SUBLINGUAL	Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A080256-002	METHYLTESTOSTERONE	25MG	TABLET / BUCCAL, SUBLINGUAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080256-001	METHYLTESTOSTERONE	10MG	TABLET / BUCCAL, SUBLINGUAL	Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A080256-002	METHYLTESTOSTERONE	25MG	TABLET / BUCCAL, SUBLINGUAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080256-001	METHYLTESTOSTERONE	10MG	TABLET / BUCCAL, SUBLINGUAL	Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080256-002	METHYLTESTOSTERONE	25MG	TABLET / BUCCAL, SUBLINGUAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080256-001	METHYLTESTOSTERONE	10MG	TABLET / BUCCAL, SUBLINGUAL	Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080256-002	METHYLTESTOSTERONE	25MG	TABLET / BUCCAL, SUBLINGUAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080256-001	METHYLTESTOSTERONE	10MG	TABLET / BUCCAL, SUBLINGUAL	Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080256-002	METHYLTESTOSTERONE	25MG	TABLET / BUCCAL, SUBLINGUAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080256-001	METHYLTESTOSTERONE	10MG	TABLET / BUCCAL, SUBLINGUAL	Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080256-002	METHYLTESTOSTERONE	25MG	TABLET / BUCCAL, SUBLINGUAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080256-001	METHYLTESTOSTERONE	10MG	TABLET / BUCCAL, SUBLINGUAL	Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A080256-002	METHYLTESTOSTERONE	25MG	TABLET / BUCCAL, SUBLINGUAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080256-001	METHYLTESTOSTERONE	10MG	TABLET / BUCCAL, SUBLINGUAL	Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A080256-002	METHYLTESTOSTERONE	25MG	TABLET / BUCCAL, SUBLINGUAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080256-001	METHYLTESTOSTERONE	10MG	TABLET / BUCCAL, SUBLINGUAL	Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080256-002	METHYLTESTOSTERONE	25MG	TABLET / BUCCAL, SUBLINGUAL	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080256-001	METHYLTESTOSTERONE	10MG	TABLET / BUCCAL, SUBLINGUAL	Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A080256-002	METHYLTESTOSTERONE	25MG	TABLET / BUCCAL, SUBLINGUAL	Approved before 1982	`f41ea6bd6efb…`

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
MethylTESTOSTERone	METHYLTESTOSTERONE	Amneal Pharmaceuticals of New York LLC	9bed4886-fcd0-4056-be8d-5bb4d15081ce	2025-05-31	Warnings, Adverse reactions	Name fallback brand name: MethylTESTOSTERone generic name: METHYLTESTOSTERONE
METHITEST	METHYLTESTOSTERONE	Amneal Pharmaceuticals of New York LLC	77bb4ef4-c10e-4acc-8225-651d003f4561	2025-05-31	Warnings, Adverse reactions	Name fallback generic name: METHYLTESTOSTERONE
Methyltestosterone	METHYLTESTOSTERONE	ANI Pharmaceuticals, Inc.	c09c4cde-9f6c-4c4f-9d96-18beb5377564	2025-05-30	Warnings, Adverse reactions	Name fallback brand name: Methyltestosterone generic name: METHYLTESTOSTERONE

Reported adverse events (FAERS/openFDA)#

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