Application 215522

Type: ANDA
Sponsor: TARO PHARM INDS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SILDENAFIL CITRATE	SILDENAFIL CITRATE	FOR SUSPENSION;ORAL	EQ 10MG BASE/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A215522-001	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL			2021-11-16

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
2026-02-19 14:30 UTC	2026-02	A215522-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL		2021-11-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215522-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL		2021-11-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215522-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2021-11-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215522-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2021-11-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215522-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2021-11-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215522-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2021-11-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215522-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2021-11-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215522-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2021-11-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215522-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2021-11-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215522-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2021-11-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215522-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2021-11-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215522-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2021-11-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215522-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2021-11-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215522-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2021-11-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215522-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2021-11-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215522-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2021-11-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215522-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2021-11-16	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215522-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2021-11-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A215522-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2021-11-16	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215522-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2021-11-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215522-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2021-11-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215522-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2021-11-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215522-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2021-11-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215522-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2021-11-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215522-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2021-11-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215522-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2021-11-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215522-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2021-11-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215522-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2021-11-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215522-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2021-11-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215522-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2021-11-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215522-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2021-11-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215522-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2021-11-16	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215522-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL		2021-11-16	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A215522-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215522-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215522-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215522-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215522-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215522-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215522-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215522-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215522-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215522-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215522-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215522-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215522-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215522-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215522-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215522-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A215522-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215522-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215522-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215522-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215522-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215522-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215522-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215522-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215522-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215522-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215522-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215522-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215522-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215522-001	AB	1	`cb3db0bc1861…`

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 2 of 4 · 61 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sildenafil Citrate	SILDENAFIL CITRATE	Zydus Lifesciences Limited	2ef4d02f-76ee-4f67-9f4f-1cd554decb31	2026-02-02	Warnings, Adverse reactions	Name fallback brand name: Sildenafil Citrate generic name: SILDENAFIL CITRATE
sildenafil CITRATE	SILDENAFIL CITRATE	Aurobindo Pharma Limited	b60b4fdc-9b78-45e6-8438-8a30f83ed976	2026-02-02	Warnings, Adverse reactions	Name fallback brand name: sildenafil CITRATE generic name: SILDENAFIL CITRATE
Sildenafil Citrate	SILDENAFIL CITRATE	Zydus Pharmaceuticals (USA) Inc.	b2f04ce4-f19c-403d-8a83-74f123e5d30a	2026-02-02	Warnings, Adverse reactions	Name fallback brand name: Sildenafil Citrate generic name: SILDENAFIL CITRATE
Sildenafil Citrate	SILDENAFIL	Advagen Pharma Ltd	ce683bbc-a1d2-4f23-b3d1-d9333d91dc55	2026-01-13	Warnings, Adverse reactions	Name fallback brand name: Sildenafil Citrate
Sildenafil Citrate	SILDENAFIL	Northwind Health Company, LLC	d9ddfd2a-1961-90f9-e053-2a95a90a7f9b	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Sildenafil Citrate
SILDENAFIL CITRATE	SILDENAFIL	Northwind Health Company, LLC	d9de0817-cac1-4ee5-e053-2a95a90a5fa7	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: SILDENAFIL CITRATE
Sildenafil Citrate	SILDENAFIL	Quallent Pharmaceuticals Health LLC	41b67fd2-3d9a-49d6-88b8-285044b98dc1	2025-11-07	Warnings, Adverse reactions	Name fallback brand name: Sildenafil Citrate
SILDENAFIL CITRATE	SILDENAFIL CITRATE	Proficient Rx LP	8780c159-8b61-402b-afbe-64f5c85d3886	2025-11-01	Warnings, Adverse reactions	Name fallback brand name: SILDENAFIL CITRATE generic name: SILDENAFIL CITRATE
SILDENAFIL CITRATE	SILDENAFIL CITRATE	Proficient Rx LP	30ce6e7f-716e-4a68-a4fb-2bb2d34ed052	2025-11-01	Warnings, Adverse reactions	Name fallback brand name: SILDENAFIL CITRATE generic name: SILDENAFIL CITRATE
Sildenafil Citrate	SILDENAFIL	Ajanta Pharma USA Inc.	2ccc6fa6-f8ae-4191-806f-a887244e516a	2025-10-08	Warnings, Adverse reactions	Name fallback brand name: Sildenafil Citrate
SILDENAFIL CITRATE	SILDENAFIL CITRATE	Proficient Rx LP	1add0cab-8873-4cd1-ab53-e05c4ac458b1	2025-10-01	Warnings, Adverse reactions	Name fallback brand name: SILDENAFIL CITRATE generic name: SILDENAFIL CITRATE
Sildenafil Citrate	SILDENAFIL	Preferred Pharmaceuticals Inc.	878b4c44-cddc-42cb-b9b5-911451ad1530	2025-09-22	Warnings, Adverse reactions	Name fallback brand name: Sildenafil Citrate
SILDENAFIL CITRATE	SILDENAFIL CITRATE	PD-Rx Pharmaceuticals, Inc.	dc4430cc-8238-4d6d-99ff-bbb9d0b51bd1	2025-04-04	Warnings, Adverse reactions	Name fallback brand name: SILDENAFIL CITRATE generic name: SILDENAFIL CITRATE
SILDENAFIL CITRATE	SILDENAFIL CITRATE	Advanced Rx of Tennessee, LLC	30cb7d6a-ce40-c794-e063-6294a90a6861	2025-03-20	Warnings, Adverse reactions	Name fallback brand name: SILDENAFIL CITRATE generic name: SILDENAFIL CITRATE
Sildenafil Citrate	SILDENAFIL	NuCare Pharmaceuticals,Inc.	155c7549-b7d6-0c06-e063-6294a90ac65c	2025-03-17	Warnings, Adverse reactions	Name fallback brand name: Sildenafil Citrate
SILDENAFIL CITRATE	SILDENAFIL CITRATE	Preferred Pharmaceuticals Inc.	5846bff2-6a93-46a7-a547-04459c590814	2025-01-20	Warnings, Adverse reactions	Name fallback brand name: SILDENAFIL CITRATE generic name: SILDENAFIL CITRATE
Sildenafil Citrate	SILDENAFIL	NuCare Pharmaceuticals, Inc.	1d614710-708e-f11c-e063-6394a90a05a5	2024-12-26	Warnings, Adverse reactions	Name fallback brand name: Sildenafil Citrate
Revatio	SILDENAFIL CITRATE	Viatris Specialty LLC	3bb9363e-b28d-4019-8aae-539233dca214	2024-12-18	Warnings, Adverse reactions	Name fallback generic name: SILDENAFIL CITRATE
SILDENAFIL CITRATE	SILDENAFIL CITRATE	A-S Medication Solutions	28a3376b-e50e-4789-9916-803ba29a1522	2024-10-25	Warnings, Adverse reactions	Name fallback brand name: SILDENAFIL CITRATE generic name: SILDENAFIL CITRATE
Sildenafil Citrate	SILDENAFIL CITRATE	NuCare Pharmaceuticals, Inc.	20ead8ca-7cec-2d80-e063-6394a90af548	2024-08-30	Warnings, Adverse reactions	Name fallback brand name: Sildenafil Citrate generic name: SILDENAFIL CITRATE

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
51672-4231	Sildenafil	SILDENAFIL CITRATE	Taro Pharmaceuticals U.S.A. Inc.	ANDA	Current