Application 210329

Type: ANDA
Sponsor: JUBILANT GENERICS

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
A210329-001	TADALAFIL	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2026-05-15
A210329-002	TADALAFIL	TADALAFIL	5MG	TABLET / ORAL	AB1	2026-05-15
A210329-003	TADALAFIL	TADALAFIL	10MG	TABLET / ORAL	AB1	2026-05-15
A210329-004	TADALAFIL	TADALAFIL	20MG	TABLET / ORAL	AB1	2026-05-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210329-001	AB1
A210329-002	AB1
A210329-003	AB1
A210329-004	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.

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	A210329-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2026-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210329-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2026-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210329-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2026-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210329-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2026-05-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210329-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2026-05-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210329-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2026-05-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210329-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2026-05-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210329-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2026-05-15	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210329-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2026-05-15	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210329-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2026-05-15	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210329-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2026-05-15	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210329-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2026-05-15	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A210329-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210329-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210329-003	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210329-004	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210329-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210329-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210329-003	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210329-004	AB1	1	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210329-001	AB1	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210329-002	AB1	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210329-003	AB1	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210329-004	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 8 of 8 · 144 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tadalafil	TADALAFIL	Dr.Reddys Laboratories Inc	61955171-ca57-e300-1983-9472a56ca976	2020-09-30	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	Dr.Reddys Laboratories Inc	22b8a2e3-d1b8-f193-45fa-77cc62a1b941	2020-01-30	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	Amneal Pharmaceuticals NY LLC	2cad2167-dbd1-4df8-b407-b270487d027b	2019-10-25	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	Camber Pharmaceuticals, Inc.	a3892605-4eb1-4d6e-a675-f7f7d4302f38	2019-03-26	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.