Application 212440

Type: ANDA
Sponsor: ALKEM LABS 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 44.

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
A212440-001	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB		2019-11-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212440-001	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 · 41 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
2026-10-15 13:18:30	2026-09	A212440-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2019-11-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A212440-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2019-11-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212440-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2019-11-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212440-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2019-11-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212440-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2019-11-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212440-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2019-11-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212440-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2019-11-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212440-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2019-11-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212440-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2019-11-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212440-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2019-11-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212440-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2019-11-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212440-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2019-11-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212440-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2019-11-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212440-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2019-11-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212440-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2019-11-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212440-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2019-11-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212440-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2019-11-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212440-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2019-11-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212440-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2019-11-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212440-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2019-11-27	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212440-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2019-11-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212440-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2019-11-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212440-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2019-11-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212440-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2019-11-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212440-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2019-11-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212440-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2019-11-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212440-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2019-11-27	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212440-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2019-11-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212440-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2019-11-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212440-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2019-11-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212440-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2019-11-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212440-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2019-11-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212440-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2019-11-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212440-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2019-11-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212440-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2019-11-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212440-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2019-11-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212440-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2019-11-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212440-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2019-11-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212440-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2019-11-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212440-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2019-11-27	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A212440-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A212440-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212440-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212440-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212440-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212440-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212440-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212440-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212440-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212440-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212440-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212440-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212440-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212440-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212440-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212440-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212440-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212440-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212440-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212440-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212440-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212440-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212440-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212440-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212440-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212440-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212440-001	AB	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212440-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212440-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212440-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212440-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212440-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212440-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212440-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212440-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212440-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212440-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212440-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212440-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212440-001	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 3 of 3 · 56 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SILDENAFIL CITRATE	SILDENAFIL CITRATE	A-S Medication Solutions	6d79946b-72a9-4d1b-a84b-9d1a679a82e2	2024-06-18	Warnings, Adverse reactions	Name fallback brand name: SILDENAFIL CITRATE generic name: SILDENAFIL CITRATE
Sildenafil Citrate	SILDENAFIL	NuCare Pharmaceuticals,Inc.	0bb3eb8d-05cd-b4cd-e063-6294a90a94bb	2024-05-15	Warnings, Adverse reactions	Name fallback brand name: Sildenafil Citrate
Sildenafil	SILDENAFIL CITRATE	ANI Pharmaceuticals, Inc.	083da718-e934-4941-b083-a19b4ebe3935	2024-01-22	Warnings, Adverse reactions	Name fallback generic name: SILDENAFIL CITRATE
sildenafil citrate	SILDENAFIL CITRATE	Novadoz Pharmaceuticals LLC	18b327c1-19c9-4e33-ae02-de7cc900149c	2024-01-01	Warnings, Adverse reactions	Name fallback brand name: sildenafil citrate generic name: SILDENAFIL CITRATE
Sildenafil Citrate	SILDENAFIL	Proficient Rx LP	88825206-1b91-4d95-876c-71100912d378	2024-01-01	Warnings, Adverse reactions	Name fallback brand name: Sildenafil Citrate
Sildenafil Citrate	SILDENAFIL	A-S Medication Solutions	bf1a22a2-6a69-46c9-933d-e474e88637e9	2023-11-24	Warnings, Adverse reactions	Name fallback brand name: Sildenafil Citrate
Viagra	SILDENAFIL CITRATE	Viatris Specialty LLC	d905dc8d-917f-4ea3-a4ee-a1ecf6967d4e	2023-11-17	Warnings, Adverse reactions	Name fallback generic name: SILDENAFIL CITRATE
Sildenafil Citrate	SILDENAFIL	Proficient Rx LP	b9b1d6ee-da42-4ef2-ab93-cd36d7f34150	2023-10-01	Warnings, Adverse reactions	Name fallback brand name: Sildenafil Citrate
SILDENAFIL CITRATE	SILDENAFIL CITRATE	Asclemed USA, Inc.	49a95b25-08b3-4cfe-a60b-c5132c280be2	2023-09-13	Warnings, Adverse reactions	Name fallback brand name: SILDENAFIL CITRATE generic name: SILDENAFIL CITRATE
Sildenafil Citrate	SILDENAFIL CITRATE	ANI Pharmaceuticals, Inc.	6d8dbaa6-d61a-46ae-a641-f664104f4714	2023-09-05	Warnings, Adverse reactions	Name fallback brand name: Sildenafil Citrate generic name: SILDENAFIL CITRATE
Sildenafil Citrate	SILDENAFIL	Asclemed USA, Inc.	0500a861-359f-4e12-beb5-0cac8cd6ae1c	2023-05-10	Warnings, Adverse reactions	Name fallback brand name: Sildenafil Citrate
Revatio	SILDENAFIL CITRATE	PFIZER LABORATORIES DIV PFIZER INC	f158fe10-d5dc-4432-b2c9-fc665401291b	2023-01-27	Warnings, Adverse reactions	Name fallback generic name: SILDENAFIL CITRATE
SILDENAFIL CITRATE	SILDENAFIL CITRATE	Proficient Rx LP	59b623bc-fbdd-4f32-8327-0d600763f429	2022-11-01	Warnings, Adverse reactions	Name fallback brand name: SILDENAFIL CITRATE generic name: SILDENAFIL CITRATE
Sildenafil Citrate	SILDENAFIL	TruPharma LLC	c8864c64-22ad-402b-a1e8-cfb53fa02e80	2020-06-22	Warnings, Adverse reactions	Name fallback brand name: Sildenafil Citrate
Sildenafil Citrate	SILDENAFIL	Proficient Rx LP	9ebc1a11-3f4b-4eb3-89f5-f430a330887d	2019-10-01	Warnings, Adverse reactions	Name fallback brand name: Sildenafil Citrate
Viagra	SILDENAFIL CITRATE	PFIZER LABORATORIES DIV PFIZER INC	0b0be196-0c62-461c-94f4-9a35339b4501	2017-12-15	Warnings, Adverse reactions	Name fallback generic name: SILDENAFIL CITRATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67877-648	Sildenafil Citrate	Sildenafil Citrate	Ascend Laboratories, LLC	ANDA	Current
67877-648	Sildenafil Citrate	Sildenafil Citrate	Ascend Laboratories, LLC	ANDA	Current
67877-648	Sildenafil Citrate	Sildenafil Citrate	Ascend Laboratories, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
59599	ORIG	2019-08-06