Application 200630

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TADALAFIL	TADALAFIL	TABLET;ORAL	20MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A200630-001	TADALAFIL	TADALAFIL	20MG	TABLET / ORAL			2018-08-03

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
2026-02-19 14:30 UTC	2026-02	A200630-001	TADALAFIL	20MG	TABLET / ORAL		2018-08-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200630-001	TADALAFIL	20MG	TABLET / ORAL		2018-08-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200630-001	TADALAFIL	20MG	TABLET / ORAL		2018-08-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200630-001	TADALAFIL	20MG	TABLET / ORAL		2018-08-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200630-001	TADALAFIL	20MG	TABLET / ORAL		2018-08-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200630-001	TADALAFIL	20MG	TABLET / ORAL		2018-08-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200630-001	TADALAFIL	20MG	TABLET / ORAL		2018-08-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200630-001	TADALAFIL	20MG	TABLET / ORAL		2018-08-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200630-001	TADALAFIL	20MG	TABLET / ORAL		2018-08-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200630-001	TADALAFIL	20MG	TABLET / ORAL		2018-08-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200630-001	TADALAFIL	20MG	TABLET / ORAL		2018-08-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200630-001	TADALAFIL	20MG	TABLET / ORAL		2018-08-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200630-001	TADALAFIL	20MG	TABLET / ORAL		2018-08-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200630-001	TADALAFIL	20MG	TABLET / ORAL		2018-08-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200630-001	TADALAFIL	20MG	TABLET / ORAL		2018-08-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200630-001	TADALAFIL	20MG	TABLET / ORAL		2018-08-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200630-001	TADALAFIL	20MG	TABLET / ORAL		2018-08-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200630-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2018-08-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200630-001	TADALAFIL	20MG	TABLET / ORAL		2018-08-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200630-001	TADALAFIL	20MG	TABLET / ORAL		2018-08-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200630-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2018-08-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200630-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2018-08-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200630-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2018-08-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200630-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2018-08-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200630-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2018-08-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200630-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2018-08-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200630-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2018-08-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200630-001	TADALAFIL	20MG	TABLET / ORAL		2018-08-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200630-001	TADALAFIL	20MG	TABLET / ORAL		2018-08-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200630-001	TADALAFIL	20MG	TABLET / ORAL		2018-08-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200630-001	TADALAFIL	20MG	TABLET / ORAL		2018-08-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200630-001	TADALAFIL	20MG	TABLET / ORAL		2018-08-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200630-001	TADALAFIL	20MG	TABLET / ORAL		2018-08-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200630-001	TADALAFIL	20MG	TABLET / ORAL		2018-08-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200630-001	TADALAFIL	20MG	TABLET / ORAL		2018-08-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200630-001	TADALAFIL	20MG	TABLET / ORAL		2018-08-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200630-001	TADALAFIL	20MG	TABLET / ORAL		2018-08-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200630-001	TADALAFIL	20MG	TABLET / ORAL		2018-08-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200630-001	TADALAFIL	20MG	TABLET / ORAL		2018-08-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200630-001	TADALAFIL	20MG	TABLET / ORAL		2018-08-03	`cb3db0bc1861…`

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	A200630-001	AB2	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200630-001	AB2	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200630-001	AB2	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200630-001	AB2	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200630-001	AB2	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200630-001	AB2	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200630-001	AB2	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200630-001	AB2	1	`ea99ee380514…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A200630-001	PC	2019-02-05	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A200630-001	PC	2019-02-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200630-001	PC	2019-02-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200630-001	PC	2019-02-05	`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 2 of 7 · 138 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TADALAFIL	TADALAFIL	Torrent Pharmaceuticals Limited	3ea7612b-b004-43ef-accc-34c8ec5146b8	2026-03-05	Warnings, Adverse reactions	Name fallback brand name: TADALAFIL generic name: TADALAFIL
tadalafil	TADALAFIL	Preferred Pharmaceuticals Inc.	fee8c2be-ccfa-4c66-abed-5e232ec762ae	2026-02-27	Warnings, Adverse reactions	Name fallback brand name: tadalafil generic name: TADALAFIL
N/A	TADALAFIL	Bostal LLC	78509a43-a907-4359-9022-f38c4f765880	2026-02-04	Warnings, Adverse reactions	Name fallback generic name: TADALAFIL
TADALAFIL	TADALAFIL	A-S Medication Solutions	cd94158b-43fa-44fc-a858-0983770efa83	2026-02-02	Warnings, Adverse reactions	Name fallback brand name: TADALAFIL generic name: TADALAFIL
Tadalafil	TADALAFIL	REMEDYREPACK INC.	2121cd9b-a2c0-4f19-a33d-939c6fb3826d	2026-01-20	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	AvKARE	b96ae7f1-7d4a-a211-e053-2995a90ab6e2	2026-01-16	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	NuCare Pharmaceutical,Inc.	48850075-ac57-abb7-e063-6394a90a7881	2026-01-16	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	NuCare Pharmaceuticals, Inc.	48892acb-43bb-a4d8-e063-6394a90a5d61	2026-01-16	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	Upsher-Smith Laboratories, LLC	ae801b15-0462-44af-99a4-affe3eed899a	2026-01-16	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	Preferred Pharmaceuticals Inc.	affacb88-4af3-4ce9-961b-7fc37b169e9a	2026-01-12	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	PD-Rx Pharmaceuticals, Inc.	f34e4747-28be-4ae5-ac9a-a825083b6a9b	2026-01-12	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	PD-Rx Pharmaceuticals, Inc.	7e236f83-14bf-4862-91fb-74d766aef6a9	2026-01-12	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	NuCare Pharmaceuticals,Inc.	cf353da9-31c6-66c2-e053-2995a90a3bb0	2026-01-09	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	Northwind Health Company, LLC	f3092f5a-b976-91ab-e053-2995a90a9b50	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	Northwind Health Company, LLC	f317fe1e-d7c4-fb8b-e053-2a95a90a5445	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	Northwind Health Company, LLC	0afd0728-256a-293b-e063-6394a90a3c5f	2025-12-26	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	Northwind Health Company, LLC	f2a132af-d75e-2ca0-e053-2a95a90a332e	2025-12-26	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED	0ea97208-5afc-4943-b35c-ea850203a794	2025-12-19	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
ADCIRCA	TADALAFIL	United Therapeutics Corporation	ff61b237-be8e-461b-8114-78c52a8ad0ae	2025-12-15	Warnings, Adverse reactions	Name fallback generic name: TADALAFIL
Tadalafil	TADALAFIL	NIVAGEN PHARMACEUTICALS, INC.	ca1d46e3-ad9b-48c7-bb7f-63ee678ccf7a	2025-12-09	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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-6976	Tadalafil	tadalafil	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6976	Tadalafil	tadalafil	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6976	Tadalafil	tadalafil	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6976	Tadalafil	tadalafil	Mylan Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
55623	ORIG	2018-09-27