Application 210716

Type: ANDA
Sponsor: GLENMARK PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TADALAFIL	TADALAFIL	TABLET;ORAL	2.5MG	No	No
002	TADALAFIL	TADALAFIL	TABLET;ORAL	5MG	No	No
003	TADALAFIL	TADALAFIL	TABLET;ORAL	10MG	No	No
004	TADALAFIL	TADALAFIL	TABLET;ORAL	20MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A210716-001	TADALAFIL	TADALAFIL	2.5MG	TABLET / ORAL	2020-12-29
A210716-002	TADALAFIL	TADALAFIL	5MG	TABLET / ORAL	2020-12-29
A210716-003	TADALAFIL	TADALAFIL	10MG	TABLET / ORAL	2020-12-29
A210716-004	TADALAFIL	TADALAFIL	20MG	TABLET / ORAL	2020-12-29

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 4 · 148 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A210716-001	TADALAFIL	2.5MG	TABLET / ORAL	2020-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210716-002	TADALAFIL	5MG	TABLET / ORAL	2020-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210716-003	TADALAFIL	10MG	TABLET / ORAL	2020-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210716-004	TADALAFIL	20MG	TABLET / ORAL	2020-12-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210716-001	TADALAFIL	2.5MG	TABLET / ORAL	2020-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210716-002	TADALAFIL	5MG	TABLET / ORAL	2020-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210716-003	TADALAFIL	10MG	TABLET / ORAL	2020-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210716-004	TADALAFIL	20MG	TABLET / ORAL	2020-12-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210716-001	TADALAFIL	2.5MG	TABLET / ORAL	2020-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210716-002	TADALAFIL	5MG	TABLET / ORAL	2020-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210716-003	TADALAFIL	10MG	TABLET / ORAL	2020-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210716-004	TADALAFIL	20MG	TABLET / ORAL	2020-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210716-001	TADALAFIL	2.5MG	TABLET / ORAL	2020-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210716-002	TADALAFIL	5MG	TABLET / ORAL	2020-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210716-003	TADALAFIL	10MG	TABLET / ORAL	2020-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210716-004	TADALAFIL	20MG	TABLET / ORAL	2020-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210716-001	TADALAFIL	2.5MG	TABLET / ORAL	2020-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210716-002	TADALAFIL	5MG	TABLET / ORAL	2020-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210716-003	TADALAFIL	10MG	TABLET / ORAL	2020-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210716-004	TADALAFIL	20MG	TABLET / ORAL	2020-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210716-001	TADALAFIL	2.5MG	TABLET / ORAL	2020-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210716-002	TADALAFIL	5MG	TABLET / ORAL	2020-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210716-003	TADALAFIL	10MG	TABLET / ORAL	2020-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210716-004	TADALAFIL	20MG	TABLET / ORAL	2020-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210716-001	TADALAFIL	2.5MG	TABLET / ORAL	2020-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210716-002	TADALAFIL	5MG	TABLET / ORAL	2020-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210716-003	TADALAFIL	10MG	TABLET / ORAL	2020-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210716-004	TADALAFIL	20MG	TABLET / ORAL	2020-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210716-001	TADALAFIL	2.5MG	TABLET / ORAL	2020-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210716-002	TADALAFIL	5MG	TABLET / ORAL	2020-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210716-003	TADALAFIL	10MG	TABLET / ORAL	2020-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210716-004	TADALAFIL	20MG	TABLET / ORAL	2020-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210716-001	TADALAFIL	2.5MG	TABLET / ORAL	2020-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210716-002	TADALAFIL	5MG	TABLET / ORAL	2020-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210716-003	TADALAFIL	10MG	TABLET / ORAL	2020-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210716-004	TADALAFIL	20MG	TABLET / ORAL	2020-12-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210716-001	TADALAFIL	2.5MG	TABLET / ORAL	2020-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210716-002	TADALAFIL	5MG	TABLET / ORAL	2020-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210716-003	TADALAFIL	10MG	TABLET / ORAL	2020-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210716-004	TADALAFIL	20MG	TABLET / ORAL	2020-12-29	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-03-12 10:30 UTC	2021-03	A210716-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A210716-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A210716-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A210716-004	AB1	1	`5aa47cf7b7d7…`

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 4 of 8 · 144 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TADALAFIL	TADALAFIL	Solco Healthcare US, LLC	05640a4d-afb7-42ae-a5bb-77dbc8412356	2025-08-31	Warnings, Adverse reactions	Name fallback brand name: TADALAFIL generic name: TADALAFIL
TADALAFIL	TADALAFIL	Preferred Pharmaceuticals Inc.	f9e9a953-2802-4bb1-91a3-a29be347801e	2025-08-29	Warnings, Adverse reactions	Name fallback brand name: TADALAFIL generic name: TADALAFIL
TADALAFIL	TADALAFIL	AvKARE	3c1c2136-099f-6232-e063-6294a90a6975	2025-08-11	Warnings, Adverse reactions	Name fallback brand name: TADALAFIL generic name: TADALAFIL
TADALAFIL	TADALAFIL	direct rx	b3ee8325-bcb2-43fd-e053-2a95a90a08c8	2025-07-09	Warnings, Adverse reactions	Name fallback brand name: TADALAFIL generic name: TADALAFIL
TADALAFIL	TADALAFIL	NuCare Pharmaceuticals, Inc.	2c4108c6-9014-4bd8-e063-6294a90a88fa	2025-07-08	Warnings, Adverse reactions	Name fallback brand name: TADALAFIL generic name: TADALAFIL
tadalafil	TADALAFIL	Asclemed USA, Inc.	fa547e3d-455a-4926-9fd9-349930898502	2025-06-25	Warnings, Adverse reactions	Name fallback brand name: tadalafil generic name: TADALAFIL
TADALAFIL	TADALAFIL	Bryant Ranch Prepack	716c586d-e524-4f3e-ab1d-7ef9184169d9	2025-06-02	Warnings, Adverse reactions	Name fallback brand name: TADALAFIL generic name: TADALAFIL
tadalafil	TADALAFIL	Proficient Rx LP	7976c4ec-ecc4-4a49-a4fe-f990aece2d3c	2025-06-01	Warnings, Adverse reactions	Name fallback brand name: tadalafil generic name: TADALAFIL
TADALAFIL	TADALAFIL	Aphena Pharma Solutions - Tennessee, LLC	351de7c2-98bf-7c88-e063-6294a90ad811	2025-05-21	Warnings, Adverse reactions	Name fallback brand name: TADALAFIL generic name: TADALAFIL
TADALAFIL	TADALAFIL	Aphena Pharma Solutions - Tennessee, LLC	34684fe8-9bf3-47fd-e063-6394a90ac80f	2025-05-14	Warnings, Adverse reactions	Name fallback brand name: TADALAFIL generic name: TADALAFIL
Tadalafil	TADALAFIL	Aphena Pharma Solutions - Tennessee, LLC	31f5dc06-50f8-47cf-e063-6294a90ad5fb	2025-04-14	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	PD-Rx Pharmaceuticals, Inc.	e899da81-a28e-4a7e-a0e6-ed6d557c0bcd	2025-04-08	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	PD-Rx Pharmaceuticals, Inc.	828f0ee1-b9fc-4743-9394-fc086bcf5345	2025-04-08	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
tadalafil	TADALAFIL	Bryant Ranch Prepack	24b82a6a-1b7e-42e6-b29b-41d4ee4d525f	2025-04-03	Warnings, Adverse reactions	Name fallback brand name: tadalafil generic name: TADALAFIL
TADALAFIL	TADALAFIL	Solco Healthcare US, LLC	491cb72b-71f2-4df9-99f8-c02d93500103	2025-03-31	Warnings, Adverse reactions	Name fallback brand name: TADALAFIL generic name: TADALAFIL
Tadalafil	TADALAFIL	NuCare Pharmaceuticals,Inc.	0a9cf85a-c17d-6890-e063-6394a90a93e9	2025-03-04	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	Teva Pharmaceuticals, Inc.	3ad14d63-42e7-493f-b56c-e02a4fd139f7	2025-03-01	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
TADALAFIL	TADALAFIL	NuCare Pharmaceuticals, Inc.	2eae8756-5c7f-2545-e063-6294a90a6d52	2025-02-21	Warnings, Adverse reactions	Name fallback brand name: TADALAFIL generic name: TADALAFIL
Tadalafil	TADALAFIL	NuCare Pharmaceuticals,Inc.	cf35291b-b05b-1182-e053-2995a90a8dee	2025-02-10	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	Aphena Pharma Solutions - Tennessee, LLC	bce03930-14c5-401f-ad17-06b7709983bc	2025-02-07	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68462-779	Tadalafil	Tadalafil	GLENMARK PHARMACEUTICALS INC., USA	ANDA	Current
68462-779	Tadalafil	Tadalafil	GLENMARK PHARMACEUTICALS INC., USA	ANDA	Current
68462-780	Tadalafil	Tadalafil	GLENMARK PHARMACEUTICALS INC., USA	ANDA	Current
68462-780	Tadalafil	Tadalafil	GLENMARK PHARMACEUTICALS INC., USA	ANDA	Current
68462-781	Tadalafil	Tadalafil	GLENMARK PHARMACEUTICALS INC., USA	ANDA	Current
68462-781	Tadalafil	Tadalafil	GLENMARK PHARMACEUTICALS INC., USA	ANDA	Current
68462-782	Tadalafil	Tadalafil	GLENMARK PHARMACEUTICALS INC., USA	ANDA	Current
68462-782	Tadalafil	Tadalafil	GLENMARK PHARMACEUTICALS INC., USA	ANDA	Current