Application 207178

Type: ANDA
Sponsor: APPCO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SILDENAFIL CITRATE	SILDENAFIL CITRATE	TABLET;ORAL	EQ 25MG BASE	No	No
002	SILDENAFIL CITRATE	SILDENAFIL CITRATE	TABLET;ORAL	EQ 50MG BASE	No	No
003	SILDENAFIL CITRATE	SILDENAFIL CITRATE	TABLET;ORAL	EQ 100MG BASE	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A207178-001	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-03-02
A207178-002	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-03-02
A207178-003	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A207178-001	AB
A207178-002	AB
A207178-003	AB

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 3 · 114 observed 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
2026-08-18 06:07:40	2026-07	A207178-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-03-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207178-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-03-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207178-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207178-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-03-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207178-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-03-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207178-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207178-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-03-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207178-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-03-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207178-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207178-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-03-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207178-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-03-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207178-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207178-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-03-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207178-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-03-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207178-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207178-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-03-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207178-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-03-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207178-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207178-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-03-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207178-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-03-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207178-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207178-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-03-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207178-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-03-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207178-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207178-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-03-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207178-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-03-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207178-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207178-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-03-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207178-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-03-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207178-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207178-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-03-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207178-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-03-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207178-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207178-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-03-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207178-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-03-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207178-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207178-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-03-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207178-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-03-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207178-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207178-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-03-02	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 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	A207178-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207178-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207178-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207178-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207178-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207178-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207178-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207178-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207178-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207178-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207178-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207178-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207178-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207178-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207178-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207178-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207178-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207178-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207178-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207178-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207178-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207178-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207178-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207178-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207178-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207178-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207178-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207178-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207178-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207178-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207178-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207178-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207178-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207178-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207178-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207178-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207178-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207178-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207178-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207178-001	AB	1	`1e350fbaab3a…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SILDENAFIL	SILDENAFIL	Appco Pharma LLC	df1cc749-caec-4bf0-aa4d-db9dcc5257c3	2026-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207178 application number: ANDA207178
SILDENAFIL	SILDENAFIL	Aphena Pharma Solutions - Tennessee, LLC	cdab7ef5-39cb-45cc-b2bf-5f634f2f5499	2023-11-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207178 application number: ANDA207178 ndc (product): 71610-675 ndc (product): 71610-679
SILDENAFIL	SILDENAFIL	CIPLA USA INC.,	15372a7c-2935-48dc-a55a-8966719b50be	2023-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207178 application number: ANDA207178 ndc (product): 69097-952 ndc (product): 69097-953 ndc (product): 69097-951
SILDENAFIL	SILDENAFIL	Exelan Pharmaceuticals, Inc.	1883785c-a1a4-48fe-b722-afacf2875ca8	2022-08-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207178 application number: ANDA207178 ndc (product): 76282-644 ndc (product): 76282-645 ndc (product): 76282-643
SILDENAFIL	SILDENAFIL	Proficient Rx LP	7086e222-0f2b-4c02-84c0-4f8635c90993	2021-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207178 application number: ANDA207178 ndc (product): 71205-473

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69097-951	SILDENAFIL	SILDENAFIL	CIPLA USA INC.,	ANDA	Current
69097-951	SILDENAFIL	SILDENAFIL	CIPLA USA INC.,	ANDA	Current
69097-952	SILDENAFIL	SILDENAFIL	CIPLA USA INC.,	ANDA	Current
69097-952	SILDENAFIL	SILDENAFIL	CIPLA USA INC.,	ANDA	Current
69097-953	SILDENAFIL	SILDENAFIL	CIPLA USA INC.,	ANDA	Current
69097-953	SILDENAFIL	SILDENAFIL	CIPLA USA INC.,	ANDA	Current
71205-473	SILDENAFIL	SILDENAFIL	Proficient Rx LP	ANDA	Current
71205-473	SILDENAFIL	SILDENAFIL	Proficient Rx LP	ANDA	Current
71610-675	SILDENAFIL	SILDENAFIL	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-675	SILDENAFIL	SILDENAFIL	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-675	SILDENAFIL	SILDENAFIL	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-679	SILDENAFIL	SILDENAFIL	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-679	SILDENAFIL	SILDENAFIL	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
76282-643	SILDENAFIL	SILDENAFIL	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-643	SILDENAFIL	SILDENAFIL	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-644	SILDENAFIL	SILDENAFIL	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-644	SILDENAFIL	SILDENAFIL	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-645	SILDENAFIL	SILDENAFIL	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-645	SILDENAFIL	SILDENAFIL	Exelan Pharmaceuticals, Inc.	ANDA	Current