Application 216318

Type: NDA
Sponsor: SLAYBACK PHARMA LLC

Application Products#

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

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

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
N216318-001	AZMIRO	TESTOSTERONE CYPIONATE	200MG/ML (200MG/ML)	SOLUTION / INTRAMUSCULAR		RLD, RS	2022-06-02

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N216318-001	11311554	2039-03-25	Drug product	2022-06-03
N216318-001	11642355	2039-03-25	Drug product	2023-05-12
N216318-001	12138271	2039-03-25	Drug product	2024-11-14

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N216318-001	AZMIRO	200MG/ML (200MG/ML)	SOLUTION / INTRAMUSCULAR	RLD, RS	2022-06-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216318-001	AZMIRO	200MG/ML (200MG/ML)	SOLUTION / INTRAMUSCULAR	RLD, RS	2022-06-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216318-001	AZMIRO	200MG/ML (200MG/ML)	SOLUTION / INTRAMUSCULAR	RLD, RS	2022-06-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216318-001	AZMIRO	200MG/ML (200MG/ML)	SOLUTION / INTRAMUSCULAR	RLD, RS	2022-06-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216318-001	AZMIRO	200MG/ML (200MG/ML)	SOLUTION / INTRAMUSCULAR	RLD, RS	2022-06-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216318-001	AZMIRO	200MG/ML (200MG/ML)	SOLUTION / INTRAMUSCULAR	RLD, RS	2022-06-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216318-001	AZMIRO	200MG/ML (200MG/ML)	SOLUTION / INTRAMUSCULAR	RLD, RS	2022-06-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216318-001	AZMIRO	200MG/ML (200MG/ML)	SOLUTION / INTRAMUSCULAR	RLD, RS	2022-06-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216318-001	TESTOSTERONE CYPIONATE	200MG/ML (200MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-06-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216318-001	AZMIRO	200MG/ML (200MG/ML)	SOLUTION / INTRAMUSCULAR	RLD, RS	2022-06-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216318-001	TESTOSTERONE CYPIONATE	200MG/ML (200MG/ML)	SOLUTION / INTRAMUSCULAR	RLD, RS	2022-06-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216318-001	TESTOSTERONE CYPIONATE	200MG/ML (200MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-06-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216318-001	TESTOSTERONE CYPIONATE	200MG/ML (200MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-06-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216318-001	TESTOSTERONE CYPIONATE	200MG/ML (200MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-06-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216318-001	TESTOSTERONE CYPIONATE	200MG/ML (200MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-06-02	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216318-001	TESTOSTERONE CYPIONATE	200MG/ML (200MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-06-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N216318-001	TESTOSTERONE CYPIONATE	200MG/ML (200MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-06-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N216318-001	TESTOSTERONE CYPIONATE	200MG/ML (200MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-06-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216318-001	TESTOSTERONE CYPIONATE	200MG/ML (200MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-06-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N216318-001	TESTOSTERONE CYPIONATE	200MG/ML (200MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-06-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N216318-001	TESTOSTERONE CYPIONATE	200MG/ML (200MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-06-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N216318-001	TESTOSTERONE CYPIONATE	200MG/ML (200MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-06-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N216318-001	TESTOSTERONE CYPIONATE	200MG/ML (200MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-06-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N216318-001	TESTOSTERONE CYPIONATE	200MG/ML (200MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-06-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N216318-001	TESTOSTERONE CYPIONATE	200MG/ML (200MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-06-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N216318-001	TESTOSTERONE CYPIONATE	200MG/ML (200MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-06-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N216318-001	TESTOSTERONE CYPIONATE	200MG/ML (200MG/ML)	SOLUTION / INTRAMUSCULAR	RLD, RS	2022-06-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N216318-001	TESTOSTERONE CYPIONATE	200MG/ML (200MG/ML)	SOLUTION / INTRAMUSCULAR	RLD, RS	2022-06-02	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216318-001	AZMIRO	200MG/ML (200MG/ML)	SOLUTION / INTRAMUSCULAR	RLD, RS	2022-06-02	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 62 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N216318-001	11311554	2039-03-25	Drug product	2022-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216318-001	11642355	2039-03-25	Drug product	2023-05-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216318-001	12138271	2039-03-25	Drug product	2024-11-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216318-001	11311554	2039-03-25	Drug product	2022-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216318-001	11642355	2039-03-25	Drug product	2023-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216318-001	12138271	2039-03-25	Drug product	2024-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216318-001	11311554	2039-03-25	Drug product	2022-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216318-001	11642355	2039-03-25	Drug product	2023-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216318-001	12138271	2039-03-25	Drug product	2024-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216318-001	11311554	2039-03-25	Drug product	2022-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216318-001	11642355	2039-03-25	Drug product	2023-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216318-001	12138271	2039-03-25	Drug product	2024-11-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216318-001	11311554	2039-03-25	Drug product	2022-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216318-001	11642355	2039-03-25	Drug product	2023-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216318-001	12138271	2039-03-25	Drug product	2024-11-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216318-001	11311554	2039-03-25	Drug product	2022-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216318-001	11642355	2039-03-25	Drug product	2023-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216318-001	12138271	2039-03-25	Drug product	2024-11-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216318-001	11311554	2039-03-25	Drug product	2022-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216318-001	11642355	2039-03-25	Drug product	2023-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216318-001	12138271	2039-03-25	Drug product	2024-11-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216318-001	11311554	2039-03-25	Drug product	2022-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216318-001	11642355	2039-03-25	Drug product	2023-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216318-001	12138271	2039-03-25	Drug product	2024-11-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216318-001	11311554	2039-03-25	Drug product	2022-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216318-001	11642355	2039-03-25	Drug product	2023-05-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216318-001	11311554	2039-03-25	Drug product	2022-06-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216318-001	11642355	2039-03-25	Drug product	2023-05-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216318-001	11311554	2039-03-25	Drug product	2022-06-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216318-001	11642355	2039-03-25	Drug product	2023-05-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216318-001	11311554	2039-03-25	Drug product	2022-06-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216318-001	11642355	2039-03-25	Drug product	2023-05-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216318-001	11311554	2039-03-25	Drug product	2022-06-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216318-001	11642355	2039-03-25	Drug product	2023-05-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216318-001	11311554	2039-03-25	Drug product	2022-06-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216318-001	11642355	2039-03-25	Drug product	2023-05-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216318-001	11311554	2039-03-25	Drug product	2022-06-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N216318-001	11642355	2039-03-25	Drug product	2023-05-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N216318-001	11311554	2039-03-25	Drug product	2022-06-03	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216318-001	11311554	2039-03-25	Drug product	2022-06-03	`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
AZMIRO	TESTOSTERONE CYPIONATE	Azurity Pharmaceuticals, Inc.	235b5625-570d-3fba-e063-6394a90aa2d1	2025-07-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 216318 application number: NDA216318

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71225-127	TESTOSTERONE	TESTOSTERONE CYPIONATE	Slayback Pharma LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82875	SUPPL	2025-07-15
82840	SUPPL	2025-07-14
82839	SUPPL	2025-07-14
81684	SUPPL	2025-03-24
80645	SUPPL	2024-12-19
77386	SUPPL	2024-03-04
77384	SUPPL	2024-02-02
73619	ORIG	2023-02-28
71211	ORIG	2022-06-03
71210	ORIG	2022-06-03
71209	ORIG	2022-06-03