Application 209302

Type: ANDA
Sponsor: UMEDICA LABS PVT LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SILDENAFIL CITRATE	SILDENAFIL CITRATE	TABLET;ORAL	EQ 50MG BASE	No	No
002	SILDENAFIL CITRATE	SILDENAFIL CITRATE	TABLET;ORAL	EQ 100MG BASE	No	No
003	SILDENAFIL CITRATE	SILDENAFIL CITRATE	TABLET;ORAL	EQ 25MG 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
A209302-001	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-08-25
A209302-002	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-08-25
A209302-003	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2021-06-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209302-001	AB
A209302-002	AB
A209302-003	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 · 110 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	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-08-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-08-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2021-06-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2021-06-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2021-06-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	BX	2020-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	BX	2020-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	BX	2021-06-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	BX	2020-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	BX	2020-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	BX	2021-06-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	BX	2020-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	BX	2020-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	BX	2021-06-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	BX	2020-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	BX	2020-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	BX	2021-06-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	BX	2020-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	BX	2020-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	BX	2021-06-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	BX	2020-08-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	BX	2020-08-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	BX	2021-06-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	BX	2020-08-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	BX	2020-08-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	BX	2021-06-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	BX	2020-08-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	BX	2020-08-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	BX	2021-06-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	BX	2020-08-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	BX	2020-08-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	BX	2021-06-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	BX	2020-08-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	BX	2020-08-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	BX	2021-06-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-08-25	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 110 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	A209302-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209302-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209302-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209302-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209302-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209302-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209302-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209302-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209302-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209302-001	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209302-002	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209302-003	BX	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209302-001	BX	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209302-002	BX	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209302-003	BX	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209302-001	BX	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209302-002	BX	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209302-003	BX	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209302-001	BX	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209302-002	BX	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209302-003	BX	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209302-001	BX	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209302-002	BX	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209302-003	BX	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209302-001	BX	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209302-002	BX	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209302-003	BX	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209302-001	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209302-002	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209302-003	BX	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209302-001	BX	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209302-002	BX	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209302-003	BX	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209302-001	BX	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209302-002	BX	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209302-003	BX	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209302-001	BX	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209302-002	BX	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209302-003	BX	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209302-001	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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SILDENAFIL CITRATE	SILDENAFIL CITRATE	PD-Rx Pharmaceuticals, Inc.	00ee09dd-2de0-4dc4-85f6-b51ed6eabd5b	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209302 application number: ANDA209302
SILDENAFIL CITRATE	SILDENAFIL CITRATE	PD-Rx Pharmaceuticals, Inc.	f1122baa-8dee-43fc-bd3d-501a55b696b3	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209302 application number: ANDA209302
SILDENAFIL CITRATE	SILDENAFIL CITRATE	Umedica Laboratories USA Inc.	90477a51-63ba-43f4-a74b-4659a946093c	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209302 application number: ANDA209302
SILDENAFIL CITRATE	SILDENAFIL CITRATE	NIVAGEN PHARMACEUTICALS, INC.	5ac95dd0-57e4-495c-bf8d-b2e5bbe33e20	2026-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209302 application number: ANDA209302 ndc (product): 75834-241 ndc (product): 75834-272 ndc (product): 75834-240
SILDENAFIL CITRATE	SILDENAFIL CITRATE	Northstar Rx LLC	8127ff38-2761-49ec-8ce7-7f971f521cfb	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209302 application number: ANDA209302
SILDENAFIL CITRATE	SILDENAFIL CITRATE	Proficient Rx LP	8780c159-8b61-402b-afbe-64f5c85d3886	2025-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209302 application number: ANDA209302
SILDENAFIL CITRATE	SILDENAFIL CITRATE	Proficient Rx LP	30ce6e7f-716e-4a68-a4fb-2bb2d34ed052	2025-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209302 application number: ANDA209302 ndc (product): 71205-657
SILDENAFIL CITRATE	SILDENAFIL CITRATE	Proficient Rx LP	1add0cab-8873-4cd1-ab53-e05c4ac458b1	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209302 application number: ANDA209302
SILDENAFIL CITRATE	SILDENAFIL CITRATE	PD-Rx Pharmaceuticals, Inc.	dc4430cc-8238-4d6d-99ff-bbb9d0b51bd1	2025-04-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209302 application number: ANDA209302
SILDENAFIL CITRATE	SILDENAFIL CITRATE	Advanced Rx of Tennessee, LLC	30cb7d6a-ce40-c794-e063-6294a90a6861	2025-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209302 application number: ANDA209302
SILDENAFIL CITRATE	SILDENAFIL CITRATE	Preferred Pharmaceuticals Inc.	5846bff2-6a93-46a7-a547-04459c590814	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209302 application number: ANDA209302
SILDENAFIL CITRATE	SILDENAFIL CITRATE	A-S Medication Solutions	6d79946b-72a9-4d1b-a84b-9d1a679a82e2	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209302 application number: ANDA209302
SILDENAFIL CITRATE	SILDENAFIL CITRATE	Proficient Rx LP	59b623bc-fbdd-4f32-8327-0d600763f429	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209302 application number: ANDA209302 ndc (product): 71205-721

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71205-657	SILDENAFIL CITRATE	SILDENAFIL CITRATE	Proficient Rx LP	ANDA	Current
71205-657	SILDENAFIL CITRATE	SILDENAFIL CITRATE	Proficient Rx LP	ANDA	Current
71205-657	SILDENAFIL CITRATE	SILDENAFIL CITRATE	Proficient Rx LP	ANDA	Current
71205-721	SILDENAFIL CITRATE	SILDENAFIL CITRATE	Proficient Rx LP	ANDA	Current
75834-240	SILDENAFIL CITRATE	SILDENAFIL CITRATE	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-240	SILDENAFIL CITRATE	SILDENAFIL CITRATE	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-240	SILDENAFIL CITRATE	SILDENAFIL CITRATE	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-240	SILDENAFIL CITRATE	SILDENAFIL CITRATE	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-240	SILDENAFIL CITRATE	SILDENAFIL CITRATE	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-241	SILDENAFIL CITRATE	SILDENAFIL CITRATE	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-241	SILDENAFIL CITRATE	SILDENAFIL CITRATE	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-241	SILDENAFIL CITRATE	SILDENAFIL CITRATE	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-241	SILDENAFIL CITRATE	SILDENAFIL CITRATE	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-241	SILDENAFIL CITRATE	SILDENAFIL CITRATE	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-272	SILDENAFIL CITRATE	SILDENAFIL CITRATE	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-272	SILDENAFIL CITRATE	SILDENAFIL CITRATE	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-272	SILDENAFIL CITRATE	SILDENAFIL CITRATE	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current