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 43.

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 · 43 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
2026-09-14 22:38:34	2026-08	A200630-001	TADALAFIL	20MG	TABLET / ORAL		2018-08-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200630-001	TADALAFIL	20MG	TABLET / ORAL		2018-08-03	`caaa826d4ba7…`
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…`

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 6 of 8 · 144 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tadalafil	TADALAFIL	Aurobindo Pharma Limited	a0ecc7cf-20dd-485a-b4dd-1bbc587280a7	2024-06-03	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	Aurobindo Pharma Limited	0345b81b-f946-4dd6-b49d-2a2bdd4c49c9	2024-05-24	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	Bryant Ranch Prepack	a73b0e6f-09fc-42d6-a678-1409ce746bd1	2024-05-17	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
TADALAFIL	TADALAFIL	Asclemed USA, Inc.	101f44e4-669c-4e3d-843a-a27157750f9c	2024-05-07	Warnings, Adverse reactions	Name fallback brand name: TADALAFIL generic name: TADALAFIL
TADALAFIL	TADALAFIL	NuCare Pharmaceuticals,Inc.	17947ccd-6f0e-d4cd-e063-6294a90a108a	2024-05-03	Warnings, Adverse reactions	Name fallback brand name: TADALAFIL generic name: TADALAFIL
Tadalafil	TADALAFIL	Bryant Ranch Prepack	6fd94914-0c9d-4268-8ed8-3c2690707a5d	2024-04-05	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	Bryant Ranch Prepack	a3190ceb-fb3f-45f7-a12d-4c333edaadc6	2024-04-03	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	Proficient Rx LP	a930511d-110e-4d2e-a4ca-df712f968b2d	2024-04-01	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	Proficient Rx LP	78b6659c-3a46-4998-9151-1a53afd83375	2024-04-01	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	Aphena Pharma Solutions - Tennessee, LLC	d1dd9d05-e9d3-49ea-aeda-047536a27037	2024-03-28	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
tadalafil	TADALAFIL	NuCare Pharmaceuticals,Inc.	13a107ba-cbbd-7760-e063-6394a90a1ee8	2024-03-14	Warnings, Adverse reactions	Name fallback brand name: tadalafil generic name: TADALAFIL
tadalafil	TADALAFIL	Unichem Pharmaceuticals (USA), Inc.	a7b3937e-ff03-436a-a5d4-92a4771034b6	2024-01-31	Warnings, Adverse reactions	Name fallback brand name: tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	A-S Medication Solutions	b9d71483-861b-465b-846b-d7bfd6cbac11	2023-12-26	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	A-S Medication Solutions	c1c8feb4-a85a-4f39-8c44-bc9cd77226f4	2023-12-21	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	Lupin Pharmaceuticals, Inc.	efa03afa-c412-4b31-bf26-7c3a6f7311af	2023-12-14	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	Camber Pharmaceuticals, Inc.	dc0a6a03-5ef1-4507-b888-5b559653c3e9	2023-11-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	NorthStar RxLLC	594acc15-a5bc-43b5-9659-a864b2c46eea	2023-11-10	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	Zydus Pharmaceuticals USA Inc.	cfe43ab8-8721-4db8-8810-f0072cf8f4d3	2023-11-08	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	Proficient Rx LP	7dfb450b-4d39-40e7-b115-9a96023052a0	2023-11-01	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	Asclemed USA, Inc.	51f87c9b-038c-4793-b0d5-5359ae231074	2023-10-31	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 · 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