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 2 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212440-001	AB	1	`a50c72e98297…`

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 3 · 56 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sildenafil Citrate	SILDENAFIL	Preferred Pharmaceuticals Inc.	878b4c44-cddc-42cb-b9b5-911451ad1530	2026-08-31	Warnings, Adverse reactions	Name fallback brand name: Sildenafil Citrate
Sildenafil Citrate	SILDENAFIL	NuCare Pharmaceuticals,Inc.	1b1ab00d-de9c-4614-e063-6394a90afcde	2026-08-11	Warnings, Adverse reactions	Name fallback brand name: Sildenafil Citrate
SILDENAFIL CITRATE	SILDENAFIL CITRATE	PD-Rx Pharmaceuticals, Inc.	00ee09dd-2de0-4dc4-85f6-b51ed6eabd5b	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: SILDENAFIL CITRATE generic name: SILDENAFIL CITRATE
SILDENAFIL CITRATE	SILDENAFIL CITRATE	PD-Rx Pharmaceuticals, Inc.	f1122baa-8dee-43fc-bd3d-501a55b696b3	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: SILDENAFIL CITRATE generic name: SILDENAFIL CITRATE
Sildenafil	SILDENAFIL CITRATE	Yaral Pharma Inc.	a17a970e-25a2-4807-9644-74e6d2bd2383	2026-07-17	Warnings, Adverse reactions	Name fallback generic name: SILDENAFIL CITRATE
Vybrique	SILDENAFIL CITRATE	IBSA Pharma Inc.	9213fec1-e0c0-4ef7-9718-d97922a3f4d8	2026-07-08	Warnings, Adverse reactions	Name fallback generic name: SILDENAFIL CITRATE
Sildenafil	SILDENAFIL CITRATE	Eugia US LLC	bb92d686-a81e-4b91-8048-693af0534cb3	2026-07-01	Warnings, Adverse reactions	Name fallback generic name: SILDENAFIL CITRATE
Sildenafil Citrate	SILDENAFIL	Northwind Health Company, LLC	471b8574-cb2a-1670-e063-6394a90a2a84	2026-06-23	Warnings, Adverse reactions	Name fallback brand name: Sildenafil Citrate
Sildenafil Citrate	SILDENAFIL	Bryant Ranch Prepack	824dcd79-bc82-4b3a-8028-3c1bca1a7a0a	2026-06-18	Warnings, Adverse reactions	Name fallback brand name: Sildenafil Citrate
Sildenafil Citrate	SILDENAFIL	Proficient Rx LP	3522bdcc-8113-4562-8ca1-f3eb884beaea	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: Sildenafil Citrate
SILDENAFIL CITRATE	SILDENAFIL	PD-Rx Pharmaceuticals, Inc.	ace2bb56-4992-49fe-9311-535b12eea9b4	2026-05-27	Warnings, Adverse reactions	Name fallback brand name: SILDENAFIL CITRATE
SILDENAFIL CITRATE	SILDENAFIL	PD-Rx Pharmaceuticals, Inc.	78c4551c-b922-43c9-9a5a-66377ea07bc2	2026-05-27	Warnings, Adverse reactions	Name fallback brand name: SILDENAFIL CITRATE
SILDENAFIL CITRATE	SILDENAFIL	Redpharm Drug	52614168-3a9e-335d-e063-6394a90ac27f	2026-05-22	Warnings, Adverse reactions	Name fallback brand name: SILDENAFIL CITRATE
SILDENAFIL CITRATE	SILDENAFIL	NuCare Pharmaceuticals, Inc.	36da8e3a-d17c-e42f-e063-6394a90a1ece	2026-05-18	Warnings, Adverse reactions	Name fallback brand name: SILDENAFIL CITRATE
SILDENAFIL CITRATE	SILDENAFIL	Preferred Pharmaceuticals Inc.	5f9ff0bb-5634-437a-96eb-249b910c7e81	2026-04-22	Warnings, Adverse reactions	Name fallback brand name: SILDENAFIL CITRATE
SILDENAFIL CITRATE	SILDENAFIL	Bryant Ranch Prepack	a05ab4e7-6f70-41c3-a3b7-9a2fd7a1d2d6	2026-03-30	Warnings, Adverse reactions	Name fallback brand name: SILDENAFIL CITRATE
Sildenafil Citrate	SILDENAFIL	NuCare Pharmaceuticals,Inc.	fbe75c2c-0aff-9ade-e053-6394a90a1ea4	2026-03-20	Warnings, Adverse reactions	Name fallback brand name: Sildenafil Citrate
SILDENAFIL CITRATE	SILDENAFIL	Bryant Ranch Prepack	edb0919d-cbf1-4968-b0eb-342aa811c2ce	2026-03-09	Warnings, Adverse reactions	Name fallback brand name: SILDENAFIL CITRATE
SILDENAFIL CITRATE	SILDENAFIL	Torrent Pharmaceuticals Limited	b48630b1-5208-4d00-b56f-21701f223758	2026-02-10	Warnings, Adverse reactions	Name fallback brand name: SILDENAFIL CITRATE
Sildenafil Citrate	SILDENAFIL CITRATE	Zydus Lifesciences Limited	2ef4d02f-76ee-4f67-9f4f-1cd554decb31	2026-02-02	Warnings, Adverse reactions	Name fallback brand name: Sildenafil Citrate 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