Application 216279

Type: ANDA
Sponsor: SHANDONG

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	TE codes	Approval date
A216279-001	TADALAFIL	TADALAFIL	20MG	TABLET / ORAL	AB1	2024-03-04
A216279-002	TADALAFIL	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2024-12-04
A216279-003	TADALAFIL	TADALAFIL	5MG	TABLET / ORAL	AB1	2024-12-04
A216279-004	TADALAFIL	TADALAFIL	10MG	TABLET / ORAL	AB1	2024-12-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A216279-001	AB1
A216279-002	AB1
A216279-003	AB1
A216279-004	AB1

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 · 44 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	A216279-001	TADALAFIL	20MG	TABLET / ORAL	AB1	2024-03-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216279-002	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2024-12-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216279-003	TADALAFIL	5MG	TABLET / ORAL	AB1	2024-12-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216279-004	TADALAFIL	10MG	TABLET / ORAL	AB1	2024-12-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216279-001	TADALAFIL	20MG	TABLET / ORAL	AB1	2024-03-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216279-002	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2024-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216279-003	TADALAFIL	5MG	TABLET / ORAL	AB1	2024-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216279-004	TADALAFIL	10MG	TABLET / ORAL	AB1	2024-12-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216279-001	TADALAFIL	20MG	TABLET / ORAL	AB1	2024-03-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216279-002	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2024-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216279-003	TADALAFIL	5MG	TABLET / ORAL	AB1	2024-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216279-004	TADALAFIL	10MG	TABLET / ORAL	AB1	2024-12-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216279-001	TADALAFIL	20MG	TABLET / ORAL	AB1	2024-03-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216279-002	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2024-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216279-003	TADALAFIL	5MG	TABLET / ORAL	AB1	2024-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216279-004	TADALAFIL	10MG	TABLET / ORAL	AB1	2024-12-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216279-001	TADALAFIL	20MG	TABLET / ORAL	AB1	2024-03-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216279-002	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2024-12-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216279-003	TADALAFIL	5MG	TABLET / ORAL	AB1	2024-12-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216279-004	TADALAFIL	10MG	TABLET / ORAL	AB1	2024-12-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216279-001	TADALAFIL	20MG	TABLET / ORAL	AB1	2024-03-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216279-002	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2024-12-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216279-003	TADALAFIL	5MG	TABLET / ORAL	AB1	2024-12-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216279-004	TADALAFIL	10MG	TABLET / ORAL	AB1	2024-12-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216279-001	TADALAFIL	20MG	TABLET / ORAL	AB1	2024-03-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216279-002	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2024-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216279-003	TADALAFIL	5MG	TABLET / ORAL	AB1	2024-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216279-004	TADALAFIL	10MG	TABLET / ORAL	AB1	2024-12-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216279-001	TADALAFIL	20MG	TABLET / ORAL	AB1	2024-03-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216279-002	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2024-12-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216279-003	TADALAFIL	5MG	TABLET / ORAL	AB1	2024-12-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216279-004	TADALAFIL	10MG	TABLET / ORAL	AB1	2024-12-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216279-001	TADALAFIL	20MG	TABLET / ORAL	AB1	2024-03-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216279-001	TADALAFIL	20MG	TABLET / ORAL	AB1	2024-03-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216279-001	TADALAFIL	20MG	TABLET / ORAL	AB1	2024-03-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216279-001	TADALAFIL	20MG	TABLET / ORAL	AB1	2024-03-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216279-001	TADALAFIL	20MG	TABLET / ORAL	AB1	2024-03-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216279-001	TADALAFIL	20MG	TABLET / ORAL	AB1	2024-03-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216279-001	TADALAFIL	20MG	TABLET / ORAL	AB1	2024-03-04	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216279-001	TADALAFIL	20MG	TABLET / ORAL	AB1	2024-03-04	`6a51e52b5d6a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 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	A216279-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216279-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216279-003	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216279-004	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216279-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216279-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216279-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216279-004	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216279-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216279-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216279-003	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216279-004	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216279-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216279-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216279-003	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216279-004	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216279-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216279-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216279-003	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216279-004	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216279-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216279-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216279-003	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216279-004	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216279-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216279-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216279-003	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216279-004	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216279-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216279-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216279-003	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216279-004	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216279-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216279-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216279-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216279-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216279-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216279-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216279-001	AB1	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216279-001	AB1	1	`6a51e52b5d6a…`

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 7 · 140 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tadalafil	TADALAFIL	NuCare Pharmaceuticals,Inc.	c3409762-3b2b-1cfc-e053-2995a90ab91b	2026-08-06	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	NorthStar Rx, LLC	a10d464a-6ea7-4e5a-befa-71eceacc5039	2026-07-30	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	REMEDYREPACK INC.	415bd983-86f3-4f38-917a-9805024f31cb	2026-07-09	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	Bryant Ranch Prepack	07567ae5-7345-4ab1-9b2c-c586c4da0427	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
TADALAFIL	TADALAFIL	REMEDYREPACK INC.	cec49f6c-71f1-4de7-b515-1612ae16e5db	2026-06-11	Warnings, Adverse reactions	Name fallback brand name: TADALAFIL generic name: TADALAFIL
TADALAFIL	TADALAFIL	REMEDYREPACK INC.	89a33a41-0f01-4f29-8b2f-769d649fbdcb	2026-06-10	Warnings, Adverse reactions	Name fallback brand name: TADALAFIL generic name: TADALAFIL
Cialis	TADALAFIL	Eli Lilly and Company	bcd8f8ab-81a2-4891-83db-24a0b0e25895	2026-06-03	Warnings, Adverse reactions	Name fallback generic name: TADALAFIL
TADALAFIL	TADALAFIL	Bryant Ranch Prepack	b3a58c17-f260-4125-abd1-27da00bb0719	2026-05-29	Warnings, Adverse reactions	Name fallback brand name: TADALAFIL generic name: TADALAFIL
Tadalafil	TADALAFIL	REMEDYREPACK INC.	ad288e9d-020a-43a0-9c07-320c5c3bbc1e	2026-05-27	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
tadalafil	TADALAFIL	Redpharm Drug	52505a7a-e3dd-7c4e-e063-6294a90a1473	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: tadalafil generic name: TADALAFIL
TADALAFIL	TADALAFIL	NuCare Pharmaceuticals,Inc..	16f13179-7c87-aa6c-e063-6294a90a93eb	2026-05-19	Warnings, Adverse reactions	Name fallback brand name: TADALAFIL generic name: TADALAFIL
Tadalafil	TADALAFIL	Bryant Ranch Prepack	2c2ec257-06bc-4ca4-9cf3-d0f49980e374	2026-05-14	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	Bryant Ranch Prepack	aa8d165b-0c7d-497a-b56a-7c62ebc0a5d2	2026-05-13	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	Bryant Ranch Prepack	f8def23c-55ea-4796-9735-dbcb25104835	2026-05-13	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	Bryant Ranch Prepack	c835a34a-9bae-4d88-b951-1b78ab92f388	2026-05-13	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	Umedica Laboratories USA Inc.	6caf3b55-9bf4-4355-9e25-8bf368943fdd	2026-04-26	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
TADALAFIL	TADALAFIL	REMEDYREPACK INC.	82dfea4c-9fe5-438a-917f-8f7d395ee8ca	2026-04-23	Warnings, Adverse reactions	Name fallback brand name: TADALAFIL generic name: TADALAFIL
Tadalafil	TADALAFIL	Accord Healthcare Inc.	eedf3ad9-7d40-496d-b1a9-6200010c18e1	2026-04-16	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	Amneal Pharmaceuticals NY LLC	90f38460-62ad-492e-a3da-403d5a5a5d86	2026-04-15	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
TADALAFIL	TADALAFIL	Aphena Pharma Solutions - Tennessee, LLC	351e28ca-3ae6-e535-e063-6394a90a9fb7	2026-03-23	Warnings, Adverse reactions	Name fallback brand name: TADALAFIL generic name: TADALAFIL