Application 203814

Type: ANDA
Sponsor: MACLEODS PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SILDENAFIL CITRATE	SILDENAFIL CITRATE	TABLET;ORAL	EQ 20MG 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203814-001	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB		2013-12-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203814-001	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 2 · 42 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	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`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	A203814-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203814-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203814-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203814-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203814-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203814-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203814-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203814-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203814-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203814-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203814-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203814-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203814-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203814-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203814-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203814-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203814-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203814-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203814-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203814-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203814-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203814-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203814-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203814-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203814-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203814-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203814-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203814-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203814-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203814-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203814-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203814-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203814-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203814-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203814-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203814-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203814-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203814-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203814-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203814-001	AB	1	`e64feba35796…`

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sildenafil	SILDENAFIL	American Health Packaging	f7fbfc3b-807e-4375-a6eb-8db0eaf40c9c	2025-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203814 application number: ANDA203814 ndc (product): 60687-416
Sildenafil	SILDENAFIL	Macleods Pharmaceuticals Limited	61a0ebd9-8dc9-4bcc-b07b-f3d6398ea96e	2025-06-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203814 application number: ANDA203814
Sildenafil	SILDENAFIL	BluePoint Laboratories	be6d1015-306d-44fb-8d4d-01724b8d9590	2024-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203814 application number: ANDA203814 ndc (product): 68001-363
Sildenafil	SILDENAFIL	NuCare Pharmaceuticals, Inc.	46dff4c0-9a6c-20f9-e054-00144ff8d46c	2024-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203814 application number: ANDA203814 ndc (product): 68071-2072
Sildenafil	SILDENAFIL	NuCare Pharmaceuticals,Inc.	97ccea8a-6d5a-129f-e053-2995a90aa837	2024-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203814 application number: ANDA203814 ndc (product): 68071-5115
Sildenafil	SILDENAFIL	NuCare Pharmaceuticals,Inc.	72900ed9-dbab-3f7b-e053-2a91aa0a0d24	2024-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203814 application number: ANDA203814 ndc (product): 68071-4517
Sildenafil	SILDENAFIL	Bryant Ranch Prepack	7c01fd56-5dd6-4728-9f2a-e0f5db810269	2023-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203814 application number: ANDA203814 ndc (product): 71335-1005
Sildenafil	SILDENAFIL	Macleods Pharmaceuticals Limited	d2892f4b-f5ba-42f5-b373-310241f4efa7	2023-08-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203814 application number: ANDA203814 ndc (product): 33342-121
Sildenafil	SILDENAFIL	Asclemed USA, Inc.	06571775-b651-4e23-a35b-88392aae7e13	2022-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203814 application number: ANDA203814 ndc (product): 76420-061
Sildenafil	SILDENAFIL	Bryant Ranch Prepack	85767ed7-932b-4e2b-8bba-b59bb45ce116	2020-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203814 application number: ANDA203814 ndc (product): 71335-1638
Sildenafil	SILDENAFIL	Proficient Rx LP	2538995d-2df6-4c87-978a-5513c670b60f	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203814 application number: ANDA203814 ndc (product): 63187-813

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 53 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17224-460	Sildenafil	Sildenafil	CALVIN, SCOTT AND COMPANY, INCORPORATED	ANDA	Current
33342-121	Sildenafil	Sildenafil	Macleods Pharmaceuticals Limited	ANDA	Current
43063-676	Sildenafil	Sildenafil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-676	Sildenafil	Sildenafil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-676	Sildenafil	Sildenafil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-676	Sildenafil	Sildenafil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-676	Sildenafil	Sildenafil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
45865-833	Sildenafil	Sildenafil	Medsource Pharmaceuticals	ANDA	Current
50436-1210	Sildenafil	Sildenafil	Unit Dose Services	ANDA	Current
50436-1210	Sildenafil	Sildenafil	Unit Dose Services	ANDA	Current
50436-9121	Sildenafil	Sildenafil	Unit Dose Services	ANDA	Current
50436-9121	Sildenafil	Sildenafil	Unit Dose Services	ANDA	Current
53002-2719	Sildenafil	Sildenafil	RPK Pharmaceuticals, Inc.	ANDA	Current
55700-677	Sildenafil	Sildenafil	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-677	Sildenafil	Sildenafil	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-677	Sildenafil	Sildenafil	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
60687-416	Sildenafil	Sildenafil	American Health Packaging	ANDA	Current
60687-416	Sildenafil	Sildenafil	American Health Packaging	ANDA	Current
60687-416	Sildenafil	Sildenafil	American Health Packaging	ANDA	Current
61919-826	SILDENAFIL	SILDENAFIL	DIRECT RX	ANDA	Current
61919-826	SILDENAFIL	SILDENAFIL	DirectRX	ANDA	Current
61919-826	SILDENAFIL	SILDENAFIL	DIRECT RX	ANDA	Current
61919-826	SILDENAFIL	SILDENAFIL	DIRECT RX	ANDA	Current
61919-826	SILDENAFIL	SILDENAFIL	DIRECT RX	ANDA	Current
61919-826	SILDENAFIL	SILDENAFIL	DIRECT RX	ANDA	Current
61919-826	SILDENAFIL	SILDENAFIL	DIRECT RX	ANDA	Current
61919-826	SILDENAFIL	SILDENAFIL	DIRECT RX	ANDA	Current
63187-813	Sildenafil	Sildenafil	Proficient Rx LP	ANDA	Current
63187-813	Sildenafil	Sildenafil	Proficient Rx LP	ANDA	Current
63629-8129	Sildenafil	Sildenafil	Bryant Ranch Prepack	ANDA	Current
63629-8129	Sildenafil	Sildenafil	Bryant Ranch Prepack	ANDA	Current
68001-363	Sildenafil	Sildenafil	BluePoint Laboratories	ANDA	Current
68001-363	Sildenafil	Sildenafil	BluePoint Laboratories	ANDA	Current
68001-363	Sildenafil	Sildenafil	BluePoint Laboratories	ANDA	Current
68071-1687	Sildenafil	Sildenafil	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2072	Sildenafil	Sildenafil	NuCare Pharmaceuticals, I	ANDA	Current
68071-2072	Sildenafil	Sildenafil	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-2072	Sildenafil	Sildenafil	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-2072	Sildenafil	Sildenafil	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-4517	Sildenafil	Sildenafil	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4517	Sildenafil	Sildenafil	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4517	Sildenafil	Sildenafil	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5115	Sildenafil	Sildenafil	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5115	Sildenafil	Sildenafil	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-0438	Sildenafil	Sildenafil	REMEDYREPACK INC.	ANDA	Current
70859-015	Sildenafil	Sildenafil	NuCare Pharmaceuticals, Inc.	ANDA	Current
70859-015	Sildenafil	Sildenafil	NuCare Pharmaceuticals, Inc.	ANDA	Current
71335-1005	Sildenafil	Sildenafil	Bryant Ranch Prepack	ANDA	Current
71335-1005	Sildenafil	Sildenafil	Bryant Ranch Prepack	ANDA	Current
71335-1638	Sildenafil	Sildenafil	Bryant Ranch Prepack	ANDA	Current
76420-061	Sildenafil	Sildenafil	Asclemed USA, Inc.	ANDA	Current
76420-061	Sildenafil	Sildenafil	Asclemed USA, Inc.	ANDA	Current
76519-1135	Sildenafil	Sildenafil	H. J. Harkins Company Inc.	ANDA	Current