Application 022473

Type: NDA
Sponsor: PFIZER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	REVATIO	SILDENAFIL CITRATE	SOLUTION;INTRAVENOUS	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	Yes	Yes

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
N022473-001	REVATIO	SILDENAFIL CITRATE	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022473-001	AP

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N022473-001	M-287	2026-01-31

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 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N022473-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022473-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022473-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022473-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022473-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022473-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022473-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022473-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022473-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022473-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022473-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022473-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022473-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022473-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022473-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022473-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022473-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022473-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022473-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022473-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022473-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022473-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022473-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022473-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022473-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022473-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022473-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022473-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022473-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022473-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022473-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022473-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022473-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022473-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022473-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022473-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022473-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022473-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022473-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022473-001	AP	1	`e64feba35796…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N022473-001	M-287	2026-01-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022473-001	M-287	2026-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022473-001	M-287	2026-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022473-001	M-287	2026-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022473-001	M-287	2026-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022473-001	M-287	2026-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022473-001	M-287	2026-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022473-001	M-287	2026-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022473-001	M-287	2026-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022473-001	M-287	2026-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022473-001	M-287	2026-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022473-001	M-287	2026-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022473-001	M-287	2026-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022473-001	M-287	2026-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022473-001	M-287	2026-01-31	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022473-001	M-287	2026-01-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022473-001	M-287	2026-01-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022473-001	M-287	2026-01-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022473-001	M-287	2026-01-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022473-001	M-287	2026-01-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022473-001	M-287	2026-01-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022473-001	M-287	2026-01-31	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022473-001	M-287	2026-01-31	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Revatio	SILDENAFIL CITRATE	Viatris Specialty LLC	3bb9363e-b28d-4019-8aae-539233dca214	2024-12-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022473 application number: NDA022473
Revatio	SILDENAFIL CITRATE	PFIZER LABORATORIES DIV PFIZER INC	f158fe10-d5dc-4432-b2c9-fc665401291b	2023-01-27	Warnings, Adverse reactions	Exact identifier ndc (product): 0069-0338

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0069-0338	Revatio	sildenafil citrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0338	Revatio	sildenafil citrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0338	Revatio	sildenafil citrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0338	Revatio	sildenafil citrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85167	SUPPL	2026-02-19
85166	SUPPL	2026-02-19
73688	SUPPL	2023-03-06
73684	SUPPL	2023-03-06
57316	SUPPL	2019-01-22
57243	SUPPL	2019-01-18
50674	SUPPL	2017-12-13
17631	SUPPL	2015-05-12
29767	SUPPL	2015-04-29
38750	SUPPL	2014-03-13
7443	SUPPL	2014-03-13
38752	SUPPL	2014-03-07
7446	SUPPL	2014-03-07
7445	SUPPL	2014-02-04
7444	SUPPL	2014-02-04
38751	SUPPL	2014-02-03
17630	SUPPL	2014-02-03
17629	SUPPL	2012-09-06
7442	SUPPL	2012-09-05
17628	SUPPL	2010-11-26
29766	SUPPL	2010-11-22
42534	ORIG	2010-02-18
24317	ORIG	2010-02-18
38749	ORIG	2009-11-20
7441	ORIG	2009-11-20