Application 077342

Type: ANDA
Sponsor: TEVA

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
A077342-001	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09
A077342-002	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-09
A077342-003	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077342-001	AB
A077342-002	AB
A077342-003	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 4 · 126 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	A077342-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077342-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077342-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077342-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077342-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077342-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077342-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077342-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077342-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077342-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077342-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077342-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077342-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077342-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077342-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077342-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077342-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077342-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077342-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077342-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077342-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077342-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077342-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077342-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077342-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077342-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077342-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077342-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077342-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077342-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077342-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077342-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077342-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077342-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077342-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077342-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077342-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077342-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077342-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077342-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A077342-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077342-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077342-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077342-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077342-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077342-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077342-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077342-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077342-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077342-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077342-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077342-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077342-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077342-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077342-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077342-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077342-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077342-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077342-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077342-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077342-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077342-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077342-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077342-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077342-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077342-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077342-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077342-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077342-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077342-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077342-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077342-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077342-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077342-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077342-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077342-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077342-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077342-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077342-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077342-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sildenafil	SILDENAFIL	Bryant Ranch Prepack	f9ab796c-1912-4137-abec-e8336a850a58	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077342 application number: ANDA077342 ndc (product): 71335-1777
Sildenafil	SILDENAFIL	Teva Pharmaceuticals USA, Inc.	5cbac450-f336-45bd-8d10-9ecfd21866eb	2024-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077342 application number: ANDA077342 ndc (product): 0093-5341 ndc (product): 0093-5343 ndc (product): 0093-5342
Sildenafil	SILDENAFIL	Proficient Rx LP	43a036a4-8a34-4411-ac8e-bf5063d67d48	2021-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077342 application number: ANDA077342 ndc (product): 71205-088
Sildenafil	SILDENAFIL	Proficient Rx LP	94eb1f59-2a7d-4230-9ae6-69c34d083326	2020-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077342 application number: ANDA077342 ndc (product): 71205-267

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 37 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-5341	Sildenafil	Sildenafil	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5341	Sildenafil	Sildenafil	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5341	Sildenafil	Sildenafil	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5342	Sildenafil	Sildenafil	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5342	Sildenafil	Sildenafil	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5342	Sildenafil	Sildenafil	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5343	Sildenafil	Sildenafil	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5343	Sildenafil	Sildenafil	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5343	Sildenafil	Sildenafil	Teva Pharmaceuticals USA, Inc.	ANDA	Current
42291-746	Sildenafil	Sildenafil	AvKARE, Inc.	ANDA	Current
42291-746	Sildenafil	Sildenafil	AvKARE	ANDA	Current
42291-746	Sildenafil	Sildenafil	AvKARE	ANDA	Current
42291-747	Sildenafil	Sildenafil	AvKARE, Inc.	ANDA	Current
42291-747	Sildenafil	Sildenafil	AvKARE	ANDA	Current
42291-747	Sildenafil	Sildenafil	AvKARE	ANDA	Current
42291-748	Sildenafil	Sildenafil	AvKARE, Inc.	ANDA	Current
42291-748	Sildenafil	Sildenafil	AvKARE	ANDA	Current
42291-748	Sildenafil	Sildenafil	AvKARE	ANDA	Current
50090-5039	Sildenafil	Sildenafil	A-S Medication Solutions	ANDA	Current
50090-5039	Sildenafil	Sildenafil	A-S Medication Solutions	ANDA	Current
55700-706	Sildenafil	Sildenafil	Quality Care Products, LLC	ANDA	Current
70518-1216	Sildenafil	Sildenafil	REMEDYREPACK INC.	ANDA	Current
70518-1216	Sildenafil	Sildenafil	REMEDYREPACK INC.	ANDA	Current
70518-1216	Sildenafil	Sildenafil	REMEDYREPACK INC.	ANDA	Current
70518-1216	Sildenafil	Sildenafil	REMEDYREPACK INC.	ANDA	Current
71205-088	Sildenafil	Sildenafil	Proficient Rx LP	ANDA	Current
71205-088	Sildenafil	Sildenafil	Proficient Rx LP	ANDA	Current
71205-088	Sildenafil	Sildenafil	Proficient Rx LP	ANDA	Current
71205-088	Sildenafil	Sildenafil	Proficient Rx LP	ANDA	Current
71205-267	Sildenafil	Sildenafil	Proficient Rx LP	ANDA	Current
71205-267	Sildenafil	Sildenafil	Proficient Rx LP	ANDA	Current
71205-267	Sildenafil	Sildenafil	Proficient Rx LP	ANDA	Current
71335-1777	Sildenafil	Sildenafil	Bryant Ranch Prepack	ANDA	Current
71610-237	Sildenafil	Sildenafil	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-237	Sildenafil	Sildenafil	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-256	Sildenafil	Sildenafil	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-271	Sildenafil	Sildenafil	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
50339	ORIG	2017-11-08