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 2 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	Aurobindo Pharma Limited	b60b4fdc-9b78-45e6-8438-8a30f83ed976	2026-02-02	Warnings, Adverse reactions	Name fallback brand name: sildenafil CITRATE generic name: SILDENAFIL CITRATE
Sildenafil Citrate	SILDENAFIL CITRATE	Zydus Pharmaceuticals (USA) Inc.	b2f04ce4-f19c-403d-8a83-74f123e5d30a	2026-02-02	Warnings, Adverse reactions	Name fallback brand name: Sildenafil Citrate generic name: SILDENAFIL CITRATE
Sildenafil Citrate	SILDENAFIL	Advagen Pharma Ltd	ce683bbc-a1d2-4f23-b3d1-d9333d91dc55	2026-01-13	Warnings, Adverse reactions	Name fallback brand name: Sildenafil Citrate
Sildenafil Citrate	SILDENAFIL	Northwind Health Company, LLC	d9ddfd2a-1961-90f9-e053-2a95a90a7f9b	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Sildenafil Citrate
SILDENAFIL CITRATE	SILDENAFIL	Northwind Health Company, LLC	d9de0817-cac1-4ee5-e053-2a95a90a5fa7	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: SILDENAFIL CITRATE
Sildenafil Citrate	SILDENAFIL	Quallent Pharmaceuticals Health LLC	41b67fd2-3d9a-49d6-88b8-285044b98dc1	2025-11-07	Warnings, Adverse reactions	Name fallback brand name: Sildenafil Citrate
SILDENAFIL CITRATE	SILDENAFIL CITRATE	Proficient Rx LP	8780c159-8b61-402b-afbe-64f5c85d3886	2025-11-01	Warnings, Adverse reactions	Name fallback brand name: SILDENAFIL CITRATE generic name: SILDENAFIL CITRATE
SILDENAFIL CITRATE	SILDENAFIL CITRATE	Proficient Rx LP	30ce6e7f-716e-4a68-a4fb-2bb2d34ed052	2025-11-01	Warnings, Adverse reactions	Name fallback brand name: SILDENAFIL CITRATE generic name: SILDENAFIL CITRATE
Sildenafil Citrate	SILDENAFIL	Ajanta Pharma USA Inc.	2ccc6fa6-f8ae-4191-806f-a887244e516a	2025-10-08	Warnings, Adverse reactions	Name fallback brand name: Sildenafil Citrate
SILDENAFIL CITRATE	SILDENAFIL CITRATE	PD-Rx Pharmaceuticals, Inc.	dc4430cc-8238-4d6d-99ff-bbb9d0b51bd1	2025-04-04	Warnings, Adverse reactions	Name fallback brand name: SILDENAFIL CITRATE generic name: SILDENAFIL CITRATE
SILDENAFIL CITRATE	SILDENAFIL CITRATE	Advanced Rx of Tennessee, LLC	30cb7d6a-ce40-c794-e063-6294a90a6861	2025-03-20	Warnings, Adverse reactions	Name fallback brand name: SILDENAFIL CITRATE generic name: SILDENAFIL CITRATE
Sildenafil Citrate	SILDENAFIL	NuCare Pharmaceuticals,Inc.	155c7549-b7d6-0c06-e063-6294a90ac65c	2025-03-17	Warnings, Adverse reactions	Name fallback brand name: Sildenafil Citrate
SILDENAFIL CITRATE	SILDENAFIL CITRATE	Preferred Pharmaceuticals Inc.	5846bff2-6a93-46a7-a547-04459c590814	2025-01-20	Warnings, Adverse reactions	Name fallback brand name: SILDENAFIL CITRATE generic name: SILDENAFIL CITRATE
Sildenafil Citrate	SILDENAFIL	NuCare Pharmaceuticals, Inc.	1d614710-708e-f11c-e063-6394a90a05a5	2024-12-26	Warnings, Adverse reactions	Name fallback brand name: Sildenafil Citrate
Revatio	SILDENAFIL CITRATE	Viatris Specialty LLC	3bb9363e-b28d-4019-8aae-539233dca214	2024-12-18	Warnings, Adverse reactions	Name fallback generic name: SILDENAFIL CITRATE
SILDENAFIL CITRATE	SILDENAFIL CITRATE	A-S Medication Solutions	28a3376b-e50e-4789-9916-803ba29a1522	2024-10-25	Warnings, Adverse reactions	Name fallback brand name: SILDENAFIL CITRATE generic name: SILDENAFIL CITRATE
Sildenafil Citrate	SILDENAFIL CITRATE	NuCare Pharmaceuticals, Inc.	20ead8ca-7cec-2d80-e063-6394a90af548	2024-08-30	Warnings, Adverse reactions	Name fallback brand name: Sildenafil Citrate generic name: SILDENAFIL CITRATE
Sildenafil Citrate	SILDENAFIL CITRATE	Mylan Pharmaceuticals Inc.	98a9897b-0cbc-4ea6-9ac2-4dd719a2ede0	2024-08-29	Warnings, Adverse reactions	Name fallback brand name: Sildenafil Citrate generic name: SILDENAFIL CITRATE
Sildenafil Citrate	SILDENAFIL CITRATE	Advanced Rx Pharmacy of Tennessee, LLC	f925abbe-4977-00b0-e053-6294a90a6e53	2024-07-10	Warnings, Adverse reactions	Name fallback brand name: Sildenafil Citrate generic name: SILDENAFIL CITRATE
Sildenafil Citrate	SILDENAFIL	Advanced Rx of Tennessee, LLC	1ceb575b-2687-0456-e063-6394a90aa88a	2024-07-10	Warnings, Adverse reactions	Name fallback brand 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