Application 020700

Type: NDA
Sponsor: MYLAN SPECIALITY LP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MUSE	ALPROSTADIL	SUPPOSITORY;URETHRAL	0.125MG	Yes	Yes
002	MUSE	ALPROSTADIL	SUPPOSITORY;URETHRAL	0.25MG	Yes	Yes
003	MUSE	ALPROSTADIL	SUPPOSITORY;URETHRAL	0.5MG	Yes	Yes
004	MUSE	ALPROSTADIL	SUPPOSITORY;URETHRAL	1MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N020700-001	MUSE	ALPROSTADIL	0.125MG	SUPPOSITORY / URETHRAL	RLD	1996-11-19
N020700-002	MUSE	ALPROSTADIL	0.25MG	SUPPOSITORY / URETHRAL	RLD	1996-11-19
N020700-003	MUSE	ALPROSTADIL	0.5MG	SUPPOSITORY / URETHRAL	RLD	1996-11-19
N020700-004	MUSE	ALPROSTADIL	1MG	SUPPOSITORY / URETHRAL	RLD	1996-11-19

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 4 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020700-001	MUSE	0.125MG	SUPPOSITORY / URETHRAL	RLD	1996-11-19	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020700-002	MUSE	0.25MG	SUPPOSITORY / URETHRAL	RLD, RS	1996-11-19	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020700-003	MUSE	0.5MG	SUPPOSITORY / URETHRAL	RLD, RS	1996-11-19	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020700-004	MUSE	1MG	SUPPOSITORY / URETHRAL	RLD, RS	1996-11-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020700-001	MUSE	0.125MG	SUPPOSITORY / URETHRAL	RLD	1996-11-19	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020700-002	MUSE	0.25MG	SUPPOSITORY / URETHRAL	RLD, RS	1996-11-19	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020700-003	MUSE	0.5MG	SUPPOSITORY / URETHRAL	RLD, RS	1996-11-19	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020700-004	MUSE	1MG	SUPPOSITORY / URETHRAL	RLD, RS	1996-11-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020700-001	MUSE	0.125MG	SUPPOSITORY / URETHRAL	RLD	1996-11-19	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020700-002	MUSE	0.25MG	SUPPOSITORY / URETHRAL	RLD, RS	1996-11-19	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020700-003	MUSE	0.5MG	SUPPOSITORY / URETHRAL	RLD, RS	1996-11-19	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020700-004	MUSE	1MG	SUPPOSITORY / URETHRAL	RLD, RS	1996-11-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020700-001	MUSE	0.125MG	SUPPOSITORY / URETHRAL	RLD	1996-11-19	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020700-002	MUSE	0.25MG	SUPPOSITORY / URETHRAL	RLD, RS	1996-11-19	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020700-003	MUSE	0.5MG	SUPPOSITORY / URETHRAL	RLD, RS	1996-11-19	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020700-004	MUSE	1MG	SUPPOSITORY / URETHRAL	RLD, RS	1996-11-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020700-001	MUSE	0.125MG	SUPPOSITORY / URETHRAL	RLD	1996-11-19	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020700-002	MUSE	0.25MG	SUPPOSITORY / URETHRAL	RLD, RS	1996-11-19	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020700-003	MUSE	0.5MG	SUPPOSITORY / URETHRAL	RLD, RS	1996-11-19	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020700-004	MUSE	1MG	SUPPOSITORY / URETHRAL	RLD, RS	1996-11-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020700-001	MUSE	0.125MG	SUPPOSITORY / URETHRAL	RLD	1996-11-19	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020700-002	MUSE	0.25MG	SUPPOSITORY / URETHRAL	RLD, RS	1996-11-19	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020700-003	MUSE	0.5MG	SUPPOSITORY / URETHRAL	RLD, RS	1996-11-19	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020700-004	MUSE	1MG	SUPPOSITORY / URETHRAL	RLD, RS	1996-11-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020700-001	MUSE	0.125MG	SUPPOSITORY / URETHRAL	RLD	1996-11-19	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020700-002	MUSE	0.25MG	SUPPOSITORY / URETHRAL	RLD, RS	1996-11-19	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020700-003	MUSE	0.5MG	SUPPOSITORY / URETHRAL	RLD, RS	1996-11-19	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020700-004	MUSE	1MG	SUPPOSITORY / URETHRAL	RLD, RS	1996-11-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020700-001	MUSE	0.125MG	SUPPOSITORY / URETHRAL	RLD	1996-11-19	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N020700-002	MUSE	0.25MG	SUPPOSITORY / URETHRAL	RLD, RS	1996-11-19	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N020700-003	MUSE	0.5MG	SUPPOSITORY / URETHRAL	RLD, RS	1996-11-19	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N020700-004	MUSE	1MG	SUPPOSITORY / URETHRAL	RLD, RS	1996-11-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020700-001	MUSE	0.125MG	SUPPOSITORY / URETHRAL	RLD	1996-11-19	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N020700-002	MUSE	0.25MG	SUPPOSITORY / URETHRAL	RLD, RS	1996-11-19	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N020700-003	MUSE	0.5MG	SUPPOSITORY / URETHRAL	RLD, RS	1996-11-19	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N020700-004	MUSE	1MG	SUPPOSITORY / URETHRAL	RLD, RS	1996-11-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020700-001	MUSE	0.125MG	SUPPOSITORY / URETHRAL	RLD	1996-11-19	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020700-002	MUSE	0.25MG	SUPPOSITORY / URETHRAL	RLD, RS	1996-11-19	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020700-003	MUSE	0.5MG	SUPPOSITORY / URETHRAL	RLD, RS	1996-11-19	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020700-004	MUSE	1MG	SUPPOSITORY / URETHRAL	RLD, RS	1996-11-19	`3a93d1ddd44b…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROSTIN VR PEDIATRIC	ALPROSTADIL	Pharmacia & Upjohn Company LLC	930f8c02-46a8-4cff-a484-660468ab23c3	2026-08-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ALPROSTADIL
PROSTIN VR PEDIATRIC	ALPROSTADIL	Pharmacia & Upjohn Company LLC	dea460fa-d05e-4191-8461-f185a711ad89	2026-08-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ALPROSTADIL
Alprostadil	ALPROSTADIL	Meitheal Pharmaceuticals Inc.	35d229e1-6947-435c-bf54-bfa09cca7e53	2024-06-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ALPROSTADIL
Caverject	ALPROSTADIL	Pharmacia & Upjohn Company LLC	a295fc1e-d82c-4f44-bc2d-a552bf594c98	2024-05-13	Warnings, Adverse reactions	Name fallback generic name: ALPROSTADIL
Edex	ALPROSTADIL	Endo USA, Inc.	e8b8ec8d-1318-43e4-a182-446e9f9579de	2024-03-27	Warnings, Adverse reactions	Name fallback generic name: ALPROSTADIL
Caverject Impulse	ALPROSTADIL	Pharmacia & Upjohn Company LLC	4dec1dbd-c63b-4a1b-81cb-c8d29696cc40	2024-02-29	Warnings, Adverse reactions	Name fallback generic name: ALPROSTADIL

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 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0037-8110	MUSE	Alprostadil	Meda Pharmaceuticals Inc.	NDA	Current
0037-8110	MUSE	Alprostadil	Meda Pharmaceuticals Inc.	NDA	Current
0037-8110	MUSE	Alprostadil	Meda Pharmaceuticals	NDA	Current
0037-8110	MUSE	Alprostadil	Meda Pharmaceuticals	NDA	Current
0037-8110	MUSE	Alprostadil	Meda Pharmaceuticals	NDA	Current
0037-8120	MUSE	Alprostadil	Meda Pharmaceuticals Inc.	NDA	Current
0037-8120	MUSE	Alprostadil	Meda Pharmaceuticals Inc.	NDA	Current
0037-8120	MUSE	Alprostadil	Meda Pharmaceuticals	NDA	Current
0037-8120	MUSE	Alprostadil	Meda Pharmaceuticals	NDA	Current
0037-8120	MUSE	Alprostadil	Meda Pharmaceuticals	NDA	Current
0037-8130	MUSE	Alprostadil	Meda Pharmaceuticals Inc.	NDA	Current
0037-8130	MUSE	Alprostadil	Meda Pharmaceuticals Inc.	NDA	Current
0037-8130	MUSE	Alprostadil	Meda Pharmaceuticals	NDA	Current
0037-8130	MUSE	Alprostadil	Meda Pharmaceuticals	NDA	Current
0037-8130	MUSE	Alprostadil	Meda Pharmaceuticals	NDA	Current
0037-8140	MUSE	Alprostadil	Meda Pharmaceuticals Inc.	NDA	Current
0037-8140	MUSE	Alprostadil	Meda Pharmaceuticals Inc.	NDA	Current
0037-8140	MUSE	Alprostadil	Meda Pharmaceuticals	NDA	Current
0037-8140	MUSE	Alprostadil	Meda Pharmaceuticals	NDA	Current
0037-8140	MUSE	Alprostadil	Meda Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78516	SUPPL	2024-05-20
78514	SUPPL	2024-05-20