Application 206285

Type: ANDA
Sponsor: AUROBINDO PHARMA 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	TE codes	Approval date
A206285-001	TADALAFIL	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26
A206285-002	TADALAFIL	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26
A206285-003	TADALAFIL	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26
A206285-004	TADALAFIL	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206285-001	AB1
A206285-002	AB1
A206285-003	AB1
A206285-004	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 5 · 172 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	A206285-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206285-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206285-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206285-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206285-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206285-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206285-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206285-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206285-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206285-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206285-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206285-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206285-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206285-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206285-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206285-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206285-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206285-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206285-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206285-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206285-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206285-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206285-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206285-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206285-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206285-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206285-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206285-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206285-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206285-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206285-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206285-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206285-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206285-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206285-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206285-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206285-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206285-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206285-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206285-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 5 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A206285-001	AB1	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A206285-002	AB1	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A206285-003	AB1	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A206285-004	AB1	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206285-001	AB1	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206285-002	AB1	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206285-003	AB1	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206285-004	AB1	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206285-001	AB1	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206285-002	AB1	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206285-003	AB1	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206285-004	AB1	1	`a50c72e98297…`

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tadalafil	TADALAFIL	Aurobindo Pharma Limited	0345b81b-f946-4dd6-b49d-2a2bdd4c49c9	2024-05-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206285 application number: ANDA206285 ndc (product): 65862-852 ndc (product): 65862-850 ndc (product): 65862-851 ndc (product): 65862-853

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 · 44 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
35573-409	Tadalafil	Tadalafil	Burel Pharma	ANDA	Current
35573-409	Tadalafil	Tadalafil	Burel Pharma	ANDA	Current
35573-409	Tadalafil	Tadalafil	Burel Pharmaceuticals, LLC	ANDA	Current
35573-409	Tadalafil	Tadalafil	Burel Pharma	ANDA	Current
35573-410	Tadalafil	Tadalafil	Burel Pharma	ANDA	Current
35573-410	Tadalafil	Tadalafil	Burel Pharma	ANDA	Current
35573-410	Tadalafil	Tadalafil	Burel Pharmaceuticals, LLC	ANDA	Current
35573-410	Tadalafil	Tadalafil	Burel Pharma	ANDA	Current
35573-411	Tadalafil	Tadalafil	Burel Pharma	ANDA	Current
35573-411	Tadalafil	Tadalafil	Burel Pharma	ANDA	Current
35573-411	Tadalafil	Tadalafil	Burel Pharmaceuticals, LLC	ANDA	Current
35573-411	Tadalafil	Tadalafil	Burel Pharma	ANDA	Current
35573-412	Tadalafil	Tadalafil	Burel Pharma	ANDA	Current
35573-412	Tadalafil	Tadalafil	Burel Pharma	ANDA	Current
35573-412	Tadalafil	Tadalafil	Burel Pharmaceuticals, LLC	ANDA	Current
35573-412	Tadalafil	Tadalafil	Burel Pharma	ANDA	Current
43063-969	Tadalafil	Tadalafil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-969	Tadalafil	Tadalafil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-969	Tadalafil	Tadalafil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-969	Tadalafil	Tadalafil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-969	Tadalafil	Tadalafil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-969	Tadalafil	Tadalafil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-4276	Tadalafil	Tadalafil	A-S Medication Solutions	ANDA	Current
50090-4276	Tadalafil	Tadalafil	A-S Medication Solutions	ANDA	Current
65862-850	Tadalafil	Tadalafil	Aurobindo Pharma Limited	ANDA	Current
65862-850	Tadalafil	Tadalafil	Aurobindo Pharma Limited	ANDA	Current
65862-850	Tadalafil	Tadalafil	Aurobindo Pharma Limited	ANDA	Current
65862-850	Tadalafil	Tadalafil	Aurobindo Pharma Limited	ANDA	Current
65862-850	Tadalafil	Tadalafil	Aurobindo Pharma Limited	ANDA	Current
65862-851	Tadalafil	Tadalafil	Aurobindo Pharma Limited	ANDA	Current
65862-851	Tadalafil	Tadalafil	Aurobindo Pharma Limited	ANDA	Current
65862-851	Tadalafil	Tadalafil	Aurobindo Pharma Limited	ANDA	Current
65862-851	Tadalafil	Tadalafil	Aurobindo Pharma Limited	ANDA	Current
65862-851	Tadalafil	Tadalafil	Aurobindo Pharma Limited	ANDA	Current
65862-852	Tadalafil	Tadalafil	Aurobindo Pharma Limited	ANDA	Current
65862-852	Tadalafil	Tadalafil	Aurobindo Pharma Limited	ANDA	Current
65862-852	Tadalafil	Tadalafil	Aurobindo Pharma Limited	ANDA	Current
65862-852	Tadalafil	Tadalafil	Aurobindo Pharma Limited	ANDA	Current
65862-852	Tadalafil	Tadalafil	Aurobindo Pharma Limited	ANDA	Current
65862-853	Tadalafil	Tadalafil	Aurobindo Pharma Limited	ANDA	Current
65862-853	Tadalafil	Tadalafil	Aurobindo Pharma Limited	ANDA	Current
65862-853	Tadalafil	Tadalafil	Aurobindo Pharma Limited	ANDA	Current
65862-853	Tadalafil	Tadalafil	Aurobindo Pharma Limited	ANDA	Current
65862-853	Tadalafil	Tadalafil	Aurobindo Pharma Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
54455	ORIG	2018-06-05