Application 091412

Type: ANDA
Sponsor: DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PARICALCITOL	PARICALCITOL	CAPSULE;ORAL	1MCG	No	No
002	PARICALCITOL	PARICALCITOL	CAPSULE;ORAL	2MCG	No	No
003	PARICALCITOL	PARICALCITOL	CAPSULE;ORAL	4MCG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A091412-001	PARICALCITOL	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-06-24
A091412-002	PARICALCITOL	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2014-06-24
A091412-003	PARICALCITOL	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2014-06-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A091412-001	AB
A091412-002	AB
A091412-003	AB

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 4 · 126 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
2026-08-18 06:07:40	2026-07	A091412-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-06-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091412-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2014-06-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091412-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2014-06-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091412-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091412-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2014-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091412-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2014-06-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091412-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091412-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2014-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091412-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2014-06-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091412-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-06-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091412-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2014-06-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091412-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2014-06-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091412-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-06-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091412-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2014-06-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091412-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2014-06-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091412-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-06-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091412-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2014-06-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091412-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2014-06-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091412-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-06-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091412-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2014-06-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091412-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2014-06-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091412-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-06-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091412-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2014-06-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091412-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2014-06-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091412-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-06-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091412-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2014-06-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091412-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2014-06-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091412-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-06-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091412-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2014-06-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091412-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2014-06-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091412-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-06-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091412-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2014-06-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091412-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2014-06-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091412-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-06-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091412-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2014-06-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091412-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2014-06-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091412-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-06-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091412-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2014-06-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091412-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2014-06-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091412-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-06-24	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A091412-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091412-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091412-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091412-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091412-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091412-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091412-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091412-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091412-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091412-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091412-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091412-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091412-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091412-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091412-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091412-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091412-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091412-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091412-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091412-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091412-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091412-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091412-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091412-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091412-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091412-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091412-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091412-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091412-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091412-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091412-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091412-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091412-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091412-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091412-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091412-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091412-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091412-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091412-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091412-001	AB	1	`1e350fbaab3a…`

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
Paricalcitol	PARICALCITOL	Dr. Reddy's Laboratories Limited	aa1a80e9-8778-a03e-5d53-d4b6a6363169	2017-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091412 application number: ANDA091412 ndc (product): 55111-665 ndc (product): 55111-664 ndc (product): 55111-663

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55111-663	Paricalcitol	Paricalcitol	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-664	Paricalcitol	Paricalcitol	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-665	Paricalcitol	Paricalcitol	Dr. Reddy's Laboratories Limited	ANDA	Current