Application 209654

Type: ANDA
Sponsor: AJANTA 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
A209654-001	TADALAFIL	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26
A209654-002	TADALAFIL	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26
A209654-003	TADALAFIL	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26
A209654-004	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
A209654-001	AB1
A209654-002	AB1
A209654-003	AB1
A209654-004	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	A209654-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209654-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209654-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209654-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209654-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209654-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209654-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209654-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209654-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209654-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209654-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209654-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209654-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209654-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209654-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209654-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209654-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209654-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209654-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209654-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209654-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209654-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209654-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209654-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209654-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209654-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209654-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209654-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209654-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209654-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209654-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209654-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209654-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209654-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209654-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209654-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209654-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209654-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209654-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209654-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A209654-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209654-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209654-003	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209654-004	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209654-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209654-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209654-003	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209654-004	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209654-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209654-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209654-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209654-004	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209654-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209654-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209654-003	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209654-004	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209654-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209654-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209654-003	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209654-004	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209654-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209654-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209654-003	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209654-004	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209654-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209654-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209654-003	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209654-004	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209654-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209654-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209654-003	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209654-004	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209654-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209654-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209654-003	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209654-004	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209654-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209654-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209654-003	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209654-004	AB1	1	`5bbf6a4d5a75…`

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 2 · 22 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	Exact identifier application applno (ANDA): 209654 application number: ANDA209654 ndc (product): 50090-5641
Tadalafil	TADALAFIL	NuCare Pharmaceuticals,Inc.	c3409762-3b2b-1cfc-e053-2995a90ab91b	2026-08-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654 ndc (product): 68071-2421
Tadalafil	TADALAFIL	NuCare Pharmaceuticals,Inc.	d6e8c52f-4dc3-5d54-e053-2995a90a9358	2026-08-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654 ndc (product): 68071-2632
Tadalafil	TADALAFIL	REMEDYREPACK INC.	415bd983-86f3-4f38-917a-9805024f31cb	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654 ndc (product): 70518-3434
Tadalafil	TADALAFIL	REMEDYREPACK INC.	ad288e9d-020a-43a0-9c07-320c5c3bbc1e	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	Bryant Ranch Prepack	2c2ec257-06bc-4ca4-9cf3-d0f49980e374	2026-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654 ndc (product): 71335-1823
Tadalafil	TADALAFIL	Bryant Ranch Prepack	c835a34a-9bae-4d88-b951-1b78ab92f388	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654 ndc (product): 71335-1670
Tadalafil	TADALAFIL	PD-Rx Pharmaceuticals, Inc.	f34e4747-28be-4ae5-ac9a-a825083b6a9b	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654 ndc (product): 72789-184
Tadalafil	TADALAFIL	PD-Rx Pharmaceuticals, Inc.	7e236f83-14bf-4862-91fb-74d766aef6a9	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	NuCare Pharmaceuticals,Inc.	cf353da9-31c6-66c2-e053-2995a90a3bb0	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654 ndc (product): 68071-2554
Tadalafil	TADALAFIL	Quallent Pharmaceuticals Health LLC	dc14daa3-cae9-4751-9034-b0e9c18054b4	2025-11-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	Ajanta Pharma USA Inc.	7e4cdac1-42cc-4038-a86b-4890962ed806	2025-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654 ndc (product): 27241-113 ndc (product): 27241-111 ndc (product): 27241-114 ndc (product): 27241-112
Tadalafil	TADALAFIL	Preferred Pharmaceuticals Inc.	2354c3e2-7b5f-4fdd-bbf2-7fa3c57686f8	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654 ndc (product): 68788-8292
Tadalafil	TADALAFIL	Preferred Pharmaceuticals Inc.	761dc0f8-2f65-4615-ab49-a4bcffd40ce9	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
TADALAFIL	TADALAFIL	direct rx	b3ee8325-bcb2-43fd-e053-2a95a90a08c8	2025-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654 ndc (product): 72189-145
Tadalafil	TADALAFIL	NuCare Pharmaceuticals,Inc.	0a9cf85a-c17d-6890-e063-6394a90a93e9	2025-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	Bryant Ranch Prepack	85ed0cbc-df84-44df-a9eb-f9587dbc21df	2024-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654 ndc (product): 71335-1491
Tadalafil	TADALAFIL	Bryant Ranch Prepack	185a3284-3a4f-44d3-9278-98581d33f95b	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654 ndc (product): 63629-8288
Tadalafil	TADALAFIL	Aphena Pharma Solutions - Tennessee, LLC	6213fd38-9580-4253-91d2-14c28a711c20	2023-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	Asclemed USA, Inc.	5ea24573-2d16-40d8-a46c-7b5fa8669e69	2023-03-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 59 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
27241-111	Tadalafil	Tadalafil	Ajanta Pharma USA Inc.	ANDA	Current
27241-111	Tadalafil	Tadalafil	Ajanta Pharma Limited	ANDA	Current
27241-111	Tadalafil	Tadalafil	Ajanta Pharma Limited	ANDA	Current
27241-111	Tadalafil	Tadalafil	Ajanta Pharma USA Inc.	ANDA	Current
27241-111	Tadalafil	Tadalafil	Ajanta Pharma Limited	ANDA	Current
27241-111	Tadalafil	Tadalafil	Ajanta Pharma Limited	ANDA	Current
27241-112	Tadalafil	Tadalafil	Ajanta Pharma USA Inc.	ANDA	Current
27241-112	Tadalafil	Tadalafil	Ajanta Pharma Limited	ANDA	Current
27241-112	Tadalafil	Tadalafil	Ajanta Pharma Limited	ANDA	Current
27241-112	Tadalafil	Tadalafil	Ajanta Pharma USA Inc.	ANDA	Current
27241-112	Tadalafil	Tadalafil	Ajanta Pharma Limited	ANDA	Current
27241-112	Tadalafil	Tadalafil	Ajanta Pharma Limited	ANDA	Current
27241-113	Tadalafil	Tadalafil	Ajanta Pharma USA Inc.	ANDA	Current
27241-113	Tadalafil	Tadalafil	Ajanta Pharma Limited	ANDA	Current
27241-113	Tadalafil	Tadalafil	Ajanta Pharma Limited	ANDA	Current
27241-113	Tadalafil	Tadalafil	Ajanta Pharma USA Inc.	ANDA	Current
27241-113	Tadalafil	Tadalafil	Ajanta Pharma Limited	ANDA	Current
27241-113	Tadalafil	Tadalafil	Ajanta Pharma Limited	ANDA	Current
27241-114	Tadalafil	Tadalafil	Ajanta Pharma USA Inc.	ANDA	Current
27241-114	Tadalafil	Tadalafil	Ajanta Pharma Limited	ANDA	Current
27241-114	Tadalafil	Tadalafil	Ajanta Pharma Limited	ANDA	Current
27241-114	Tadalafil	Tadalafil	Ajanta Pharma USA Inc.	ANDA	Current
27241-114	Tadalafil	Tadalafil	Ajanta Pharma Limited	ANDA	Current
27241-114	Tadalafil	Tadalafil	Ajanta Pharma Limited	ANDA	Current
50090-5344	Tadalafil	Tadalafil	A-S Medication Solutions	ANDA	Current
50090-5641	Tadalafil	Tadalafil	A-S Medication Solutions	ANDA	Current
50436-0114	Tadalafil	Tadalafil	Unit Dose Services	ANDA	Current
50436-1120	Tadalafil	Tadalafil	Unit Dose Services	ANDA	Current
50436-1120	Tadalafil	Tadalafil	Unit Dose Services	ANDA	Current
63629-8288	Tadalafil	Tadalafil	Bryant Ranch Prepack	ANDA	Current
63629-8288	Tadalafil	Tadalafil	Bryant Ranch Prepack	ANDA	Current
68071-2417	Tadalafil	Tadalafil	NUCARE PHARMACEUTICALS INC	ANDA	Current
68071-2417	Tadalafil	Tadalafil	NUCARE PHARMACEUTICALS INC	ANDA	Current
68071-2421	Tadalafil	Tadalafil	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2421	Tadalafil	Tadalafil	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2421	Tadalafil	Tadalafil	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2421	Tadalafil	Tadalafil	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2451	Tadalafil	Tadalafil	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2554	Tadalafil	Tadalafil	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2613	Tadalafil	Tadalafil	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2632	Tadalafil	Tadalafil	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-8292	Tadalafil	Tadalafil	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-3434	Tadalafil	Tadalafil	REMEDYREPACK INC.	ANDA	Current
70518-3434	Tadalafil	Tadalafil	REMEDYREPACK INC.	ANDA	Current
70518-3434	Tadalafil	Tadalafil	REMEDYREPACK INC.	ANDA	Current
71205-734	Tadalafil	Tadalafil	Proficient Rx LP	ANDA	Current
71205-735	Tadalafil	Tadalafil	Proficient Rx LP	ANDA	Current
71205-736	Tadalafil	Tadalafil	Proficient Rx LP	ANDA	Current
71335-1491	Tadalafil	Tadalafil	Bryant Ranch Prepack	ANDA	Current
71335-1491	Tadalafil	Tadalafil	Bryant Ranch Prepack	ANDA	Current
71335-1491	Tadalafil	Tadalafil	Bryant Ranch Prepack	ANDA	Current
71335-1670	Tadalafil	Tadalafil	Bryant Ranch Prepack	ANDA	Current
71335-1670	Tadalafil	Tadalafil	Bryant Ranch Prepack	ANDA	Current
71335-1670	Tadalafil	Tadalafil	Bryant Ranch Prepack	ANDA	Current
71335-1823	Tadalafil	Tadalafil	Bryant Ranch Prepack	ANDA	Current
71610-461	Tadalafil	Tadalafil	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
72189-145	TADALAFIL	TADALAFIL	direct rx	ANDA	Current
72789-184	Tadalafil	Tadalafil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-184	Tadalafil	Tadalafil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current