Application 091108

Type: ANDA
Sponsor: SANDOZ INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PARICALCITOL	PARICALCITOL	SOLUTION;INTRAVENOUS	0.002MG/ML (0.002MG/ML)	No	No
002	PARICALCITOL	PARICALCITOL	SOLUTION;INTRAVENOUS	0.005MG/ML (0.005MG/ML)	No	No
003	PARICALCITOL	PARICALCITOL	SOLUTION;INTRAVENOUS	0.01MG/2ML (0.005MG/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A091108-001	PARICALCITOL	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS	AP	2011-07-27
A091108-002	PARICALCITOL	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2011-07-27
A091108-003	PARICALCITOL	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2011-07-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091108-001	AP
A091108-002	AP
A091108-003	AP

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 2 of 4 · 132 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
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091108-002	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2011-07-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091108-003	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2011-07-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091108-001	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS	AP	2011-07-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091108-002	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2011-07-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091108-003	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2011-07-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091108-001	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS	AP	2011-07-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091108-002	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2011-07-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091108-003	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2011-07-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091108-001	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS	AP	2011-07-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091108-002	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2011-07-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091108-003	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2011-07-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091108-001	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS	AP	2011-07-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091108-002	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2011-07-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091108-003	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2011-07-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091108-001	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS	AP	2011-07-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091108-002	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2011-07-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091108-003	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2011-07-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091108-001	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS	AP	2011-07-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091108-002	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2011-07-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091108-003	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2011-07-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091108-001	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS	AP	2011-07-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091108-002	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2011-07-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091108-003	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2011-07-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091108-001	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS	AP	2011-07-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091108-002	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2011-07-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091108-003	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2011-07-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091108-001	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS	AP	2011-07-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091108-002	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2011-07-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091108-003	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2011-07-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091108-001	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS	AP	2011-07-27	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091108-002	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2011-07-27	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091108-003	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2011-07-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091108-001	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS	AP	2011-07-27	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A091108-002	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2011-07-27	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A091108-003	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2011-07-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091108-001	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS	AP	2011-07-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091108-002	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2011-07-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091108-003	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2011-07-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091108-001	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS	AP	2011-07-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091108-002	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2011-07-27	`c0c555d07b60…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A091108-001	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091108-002	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091108-003	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A091108-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091108-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091108-003	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091108-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091108-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091108-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091108-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091108-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091108-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091108-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091108-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091108-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091108-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091108-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091108-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091108-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091108-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091108-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091108-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091108-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091108-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091108-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091108-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091108-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091108-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091108-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091108-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091108-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091108-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091108-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091108-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091108-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091108-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091108-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091108-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091108-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091108-001	AP	1	`79d66fd596c7…`

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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Paricalcitol	PARICALCITOL	Bryant Ranch Prepack	664253fb-d99d-4af6-971b-95c0087406d9	2026-04-23	Warnings, Adverse reactions	Name fallback brand name: Paricalcitol generic name: PARICALCITOL
PARICALCITOL	PARICALCITOL	Eugia US LLC	6937c596-9ca4-480e-9090-b9d8a3c271c8	2025-10-23	Warnings, Adverse reactions	Name fallback brand name: PARICALCITOL generic name: PARICALCITOL
Paricalcitol	PARICALCITOL	Bryant Ranch Prepack	22a0d467-9881-458f-8b1c-1186feb96ee4	2024-08-12	Warnings, Adverse reactions	Name fallback brand name: Paricalcitol generic name: PARICALCITOL
Zemplar	PARICALCITOL	AbbVie Inc.	1b27c026-2d60-47b4-2a9c-ded1818f21b5	2024-08-07	Warnings, Adverse reactions	Name fallback generic name: PARICALCITOL
Zemplar	PARICALCITOL	AbbVie Inc.	7259652f-81bc-4ad1-bba5-d01f9fac1b80	2024-08-01	Warnings, Adverse reactions	Name fallback generic name: PARICALCITOL
Paricalcitol	PARICALCITOL	Accord Healthcare, Inc.	2b7c7587-2042-0d9c-e054-00144ff88e88	2024-07-30	Warnings, Adverse reactions	Name fallback brand name: Paricalcitol generic name: PARICALCITOL
Paricalcitol	PARICALCITOL	Bryant Ranch Prepack	52ca3d88-e85d-44a9-8aa7-eb25a8a73f6f	2024-06-11	Warnings, Adverse reactions	Name fallback brand name: Paricalcitol generic name: PARICALCITOL
Paricalcitol	PARICALCITOL	Bryant Ranch Prepack	d62d977a-bbfc-454a-a4a9-017a9f525574	2024-04-03	Warnings, Adverse reactions	Name fallback brand name: Paricalcitol generic name: PARICALCITOL
Paricalcitol	PARICALCITOL	Amneal Pharmaceuticals LLC	8e0b016c-4bda-487e-b525-63abfb772761	2024-03-23	Warnings, Adverse reactions	Name fallback brand name: Paricalcitol generic name: PARICALCITOL
Paricalcitol	PARICALCITOL	Bionpharma Inc.	755476e5-62a2-4f01-92a3-307e192ad42c	2023-12-27	Warnings, Adverse reactions	Name fallback brand name: Paricalcitol generic name: PARICALCITOL
Paricalcitol	PARICALCITOL	Aurobindo Pharma Limited	59738576-3494-4d72-98d2-6904a3778081	2023-12-06	Warnings, Adverse reactions	Name fallback brand name: Paricalcitol generic name: PARICALCITOL
Paricalcitol	PARICALCITOL	TIME CAP LABORATORIES, INC	f593b575-7537-4531-87fc-c1b0814fd018	2022-12-02	Warnings, Adverse reactions	Name fallback brand name: Paricalcitol generic name: PARICALCITOL
Paricalcitol	PARICALCITOL	West-Ward Pharmaceuticals Corp	4db985c4-3ba2-4967-898b-35af77f150de	2018-12-12	Warnings, Adverse reactions	Name fallback brand name: Paricalcitol generic name: PARICALCITOL
Paricalcitol	PARICALCITOL	MARKSANS PHARMA LIMITED	0fbaff52-f08f-42b7-8e46-c7214112901a	2017-05-26	Warnings, Adverse reactions	Name fallback brand name: Paricalcitol generic name: PARICALCITOL
Paricalcitol	PARICALCITOL	Amneal Pharmaceuticals LLC	cd937aab-6ed2-44ef-b91e-82738997ed10	2017-04-30	Warnings, Adverse reactions	Name fallback brand name: Paricalcitol generic name: PARICALCITOL
Paricalcitol	PARICALCITOL	Dr. Reddy's Laboratories Limited	aa1a80e9-8778-a03e-5d53-d4b6a6363169	2017-04-27	Warnings, Adverse reactions	Name fallback brand name: Paricalcitol generic name: PARICALCITOL

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9318	ORIG	2011-07-29