Application 206956

Type: ANDA
Sponsor: MYLAN

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	10MG	No	No
003	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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A206956-001	TADALAFIL	TADALAFIL	2.5MG	TABLET / ORAL	2019-04-29
A206956-002	TADALAFIL	TADALAFIL	10MG	TABLET / ORAL	2019-04-29
A206956-003	TADALAFIL	TADALAFIL	20MG	TABLET / ORAL	2019-04-29

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 · 129 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	A206956-001	TADALAFIL	2.5MG	TABLET / ORAL	2019-04-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206956-002	TADALAFIL	10MG	TABLET / ORAL	2019-04-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206956-003	TADALAFIL	20MG	TABLET / ORAL	2019-04-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206956-001	TADALAFIL	2.5MG	TABLET / ORAL	2019-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206956-002	TADALAFIL	10MG	TABLET / ORAL	2019-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206956-003	TADALAFIL	20MG	TABLET / ORAL	2019-04-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206956-001	TADALAFIL	2.5MG	TABLET / ORAL	2019-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206956-002	TADALAFIL	10MG	TABLET / ORAL	2019-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206956-003	TADALAFIL	20MG	TABLET / ORAL	2019-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206956-001	TADALAFIL	2.5MG	TABLET / ORAL	2019-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206956-002	TADALAFIL	10MG	TABLET / ORAL	2019-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206956-003	TADALAFIL	20MG	TABLET / ORAL	2019-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206956-001	TADALAFIL	2.5MG	TABLET / ORAL	2019-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206956-002	TADALAFIL	10MG	TABLET / ORAL	2019-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206956-003	TADALAFIL	20MG	TABLET / ORAL	2019-04-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206956-001	TADALAFIL	2.5MG	TABLET / ORAL	2019-04-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206956-002	TADALAFIL	10MG	TABLET / ORAL	2019-04-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206956-003	TADALAFIL	20MG	TABLET / ORAL	2019-04-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206956-001	TADALAFIL	2.5MG	TABLET / ORAL	2019-04-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206956-002	TADALAFIL	10MG	TABLET / ORAL	2019-04-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206956-003	TADALAFIL	20MG	TABLET / ORAL	2019-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206956-001	TADALAFIL	2.5MG	TABLET / ORAL	2019-04-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206956-002	TADALAFIL	10MG	TABLET / ORAL	2019-04-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206956-003	TADALAFIL	20MG	TABLET / ORAL	2019-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206956-001	TADALAFIL	2.5MG	TABLET / ORAL	2019-04-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206956-002	TADALAFIL	10MG	TABLET / ORAL	2019-04-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206956-003	TADALAFIL	20MG	TABLET / ORAL	2019-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206956-001	TADALAFIL	2.5MG	TABLET / ORAL	2019-04-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206956-002	TADALAFIL	10MG	TABLET / ORAL	2019-04-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206956-003	TADALAFIL	20MG	TABLET / ORAL	2019-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206956-001	TADALAFIL	2.5MG	TABLET / ORAL	2019-04-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206956-002	TADALAFIL	10MG	TABLET / ORAL	2019-04-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206956-003	TADALAFIL	20MG	TABLET / ORAL	2019-04-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206956-001	TADALAFIL	2.5MG	TABLET / ORAL	2019-04-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206956-002	TADALAFIL	10MG	TABLET / ORAL	2019-04-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206956-003	TADALAFIL	20MG	TABLET / ORAL	2019-04-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206956-001	TADALAFIL	2.5MG	TABLET / ORAL	2019-04-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206956-002	TADALAFIL	10MG	TABLET / ORAL	2019-04-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206956-003	TADALAFIL	20MG	TABLET / ORAL	2019-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206956-001	TADALAFIL	2.5MG	TABLET / ORAL	2019-04-29	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A206956-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206956-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206956-003	AB1	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206956-001	AB1	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206956-002	AB1	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206956-003	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206956-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206956-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206956-003	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206956-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206956-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206956-003	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206956-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206956-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206956-003	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206956-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A206956-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A206956-003	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206956-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A206956-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A206956-003	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206956-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A206956-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A206956-003	AB1	1	`ea99ee380514…`

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 8 · 145 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tadalafil	TADALAFIL	A-S Medication Solutions	b1840f16-a7ea-44bd-b091-5268990aedb2	2026-09-09	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	A-S Medication Solutions	81222924-29d9-4031-954d-132923867b8e	2026-09-09	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	A-S Medication Solutions	cf9431ef-ea02-457d-b83a-ce13fb963d95	2026-08-28	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
tadalafil	TADALAFIL	Bryant Ranch Prepack	394be6ef-c0f7-4cd5-8062-39fda5c1c2c4	2026-08-27	Warnings, Adverse reactions	Name fallback brand name: tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	A-S Medication Solutions	a6847ad6-3b5b-47e5-a3b5-04dc3182d72b	2026-08-25	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	NuCare Pharmaceuticals,Inc.	c3409762-3b2b-1cfc-e053-2995a90ab91b	2026-08-18	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	NuCare Pharmaceuticals,Inc.	d6e8c52f-4dc3-5d54-e053-2995a90a9358	2026-08-03	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	NuCare Pharmaceuticals,Inc.	2c277890-3c5d-5fd5-e063-6394a90af15b	2026-07-24	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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-6970	Tadalafil	tadalafil	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6970	Tadalafil	tadalafil	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6970	Tadalafil	tadalafil	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6972	Tadalafil	tadalafil	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6972	Tadalafil	tadalafil	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6972	Tadalafil	tadalafil	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6973	Tadalafil	tadalafil	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6973	Tadalafil	tadalafil	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6973	Tadalafil	tadalafil	Mylan Pharmaceuticals Inc.	ANDA	Current